# US openFDA UDI — Medical Device Database (`devone-studio/openfda-udi-api`) Actor

FDA Unique Device Identifier database. Brand names, manufacturers, GMDN terms, FDA product codes, MRI safety, GS1/HIBCC/ICCBBA identifiers. Public domain (CC0 1.0).

- **URL**: https://apify.com/devone-studio/openfda-udi-api.md
- **Developed by:** [Ti Gg](https://apify.com/devone-studio) (community)
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $1.00 / 1,000 results

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## openFDA UDI API — Medical Device Database

Search the FDA Unique Device Identifier (UDI) database by device name,
manufacturer, GMDN term, FDA product code, or GS1/HIBCC/ICCBBA
identifier. Returns brand, model, manufacturer, MRI safety, GMDN terms,
and FDA product codes. Built for **medical device vendors**, **hospital
procurement**, and **AI agents** that need to ground device questions.

### Free trial

A free Apify account gives you about **5 USD of monthly credits**, more
than enough to resolve hundreds of devices and inspect the JSON schema
before paying.

### Use cases

1. **Device recall watch** — given a brand name (e.g. `"CocoBear"`),
   pull every version's `is_discontinued` and `commercial_distribution_status`.
2. **Hospital procurement lookup** — given a GS1 DI, fetch
   `mri_safety_class`, `first_product_code_name`, and
   `first_medical_specialty` for a procurement decision.
3. **LLM medical device QA** — answer user queries about MRI safety by
   returning the top 5 records filtered by brand or model number.

### Input

```json
{
  "brand_name": "CocoBear",
  "company_name": "",
  "gmdn_term_name": "",
  "max_results": 20
}
```

| Field | Type | Default | Description |
|---|---|---|---|
| `brand_name` | string | `""` | Partial brand-name match (case-insensitive). |
| `company_name` | string | `""` | Partial company-name match (case-insensitive). |
| `version_or_model_number` | string | `""` | Model/version number. |
| `gmdn_term_name` | string | `""` | GMDN term (e.g. `Thermometer`). |
| `first_product_code` | string | `""` | FDA product code (e.g. `FLL`). |
| `first_medical_specialty` | string | `""` | FDA medical specialty. |
| `is_discontinued` | boolean | `false` | Only discontinued records. |
| `is_in_commercial_distribution` | boolean | `false` | Only currently distributed devices. |
| `max_results` | integer | `50` | Cap on returned devices. |

### Output (real run)

```json
[
  {
    "public_device_record_key": "b959e12b-023c-4c4d-a7f3-305f6d985826",
    "brand_name": "CocoBear Non-contact Infrared Thermometer",
    "company_name": "Alicn Medical Shenzhen, Inc.",
    "labeler_duns_number": "548040741",
    "version_or_model_number": "AET-R1B1-B",
    "device_count_in_base_package": 1,
    "commercial_distribution_status": "In Commercial Distribution",
    "public_version_number": "2",
    "public_version_date": "2020-12-04",
    "record_status": "Published",
    "is_discontinued": false,
    "is_in_commercial_distribution": true,
    "is_single_use": false,
    "is_sterile": false,
    "is_kit": false,
    "is_otc": false,
    "is_rx": false,
    "is_rx_or_otc": false,
    "is_combination_product": false,
    "is_hct_p": false,
    "is_direct_marking_exempt": false,
    "has_donation_id_number": false,
    "has_expiration_date": false,
    "has_lot_or_batch": false,
    "has_manufacturing_date": false,
    "has_mri_safety_info": false,
    "has_serial": false,
    "mri_safety": "Labeling does not contain MRI Safety Information",
    "mri_safety_class": null,
    "first_product_code": "FLL",
    "first_product_code_name": "Thermometer, Electronic, Clinical",
    "first_medical_specialty": "General Hospital",
    "first_regulation_number": "880.2910",
    "gmdn_term_count": 1,
    "gmdn_terms": ["Thermometer, infrared, skin"],
    "issuing_agencies": ["GS1"],
    "identifier_count": 1,
    "identifier_types": ["Primary"],
    "first_identifier_id": "06958866334019",
    "first_identifier_type": "Primary",
    "customer_contact_count": 1,
    "product_code_count": 1,
    "product_code_names": ["Thermometer, Electronic, Clinical"],
    "product_codes": ["FLL"],
    "medical_specialty_descriptions": ["General Hospital"],
    "version_age_days": 1966
  }
]
```

| Field | Type | Description |
|---|---|---|
| `public_device_record_key` | string | UDI record UUID. |
| `brand_name` / `company_name` | string | Brand and labeler. |
| `labeler_duns_number` | string | DUNS of the labeler. |
| `version_or_model_number` | string | Model/version. |
| `commercial_distribution_status` | string | `In Commercial Distribution`, `Not in Commercial Distribution`. |
| `public_version_date` | string | Date of the public record version. |
| `record_status` | string | `Published` or other. |
| `is_discontinued` / `is_in_commercial_distribution` / `is_single_use` / `is_sterile` / `is_kit` / `is_otc` / `is_rx` / `is_combination_product` / `is_hct_p` / `is_direct_marking_exempt` | boolean | Convenience flags. |
| `has_donation_id_number` / `has_expiration_date` / `has_lot_or_batch` / `has_manufacturing_date` / `has_mri_safety_info` / `has_serial` | boolean | Identifier presence flags. |
| `mri_safety` | string | Free-text MRI safety label. |
| `mri_safety_class` | string | `MR Safe`, `MR Conditional`, `MR Unsafe`, or null. |
| `first_product_code` / `first_product_code_name` | string | FDA product code and name. |
| `first_medical_specialty` | string | FDA medical specialty. |
| `first_regulation_number` | string | 21 CFR part (e.g. `880.2910`). |
| `gmdn_term_count` / `gmdn_terms` | integer / array | Global Medical Device Nomenclature terms. |
| `issuing_agencies` | array | `GS1`, `HIBCC`, `ICCBBA`. |
| `identifier_count` / `identifier_types` | integer / array | Identifier metadata. |
| `first_identifier_id` / `first_identifier_type` | string | Primary device identifier. |
| `customer_contact_count` | integer | Customer contact entries. |
| `product_code_count` / `product_code_names` / `product_codes` | integer / array | All product codes. |
| `medical_specialty_descriptions` | array | Specialty strings. |
| `version_age_days` | integer | Age of this version since `public_version_date`. |

### Pricing (pay-per-event)

- **No subscription.** Free monthly credits apply first.
- **1 result = $0.001 USD** (about $1 per 1 000 results).
- Charged per item returned in the dataset; failed runs are not charged.

### Source, licence, limits

- Source: openFDA UDI database (`/device/udi.json`).
- Licence: CC0 1.0 — public domain dedication.
- Update frequency: openFDA refreshes the UDI dataset monthly; this
  Actor reflects the upstream API at the moment of the run.
- Limits: openFDA caps each request at 1 000 records; we paginate up to
  `max_results`. Spelling for `company_name` is best-effort.

### FAQ

**How do I look up a device by GS1 barcode?**
Pass the barcode in `first_identifier_id`. Use exact match (no spaces
or hyphens).

**What's a GMDN term?**
Global Medical Device Nomenclature — an international taxonomy.
Use `gmdn_term_name` for human-friendly filtering.

**What's the difference between `mri_safety` and `mri_safety_class`?**
`mri_safety` is the free-text label FDA submitted; `mri_safety_class`
is the structured `MR Safe` / `MR Conditional` / `MR Unsafe` value (or
null when not provided).

**Why are some records `is_discontinued=true`?**
Devices remain in the database after the manufacturer stops
distributing them. Filter by `is_in_commercial_distribution=true` for
the active catalogue.

**Why is `labeler_duns_number` sometimes empty?**
Some labelers (notably outside the US) do not provide a DUNS.

**How do I find devices in a single product category?**
Use `first_product_code` (e.g. `FLL` for clinical electronic
thermometers).

### Other Actors from DevOne-Studio

- **[ted-tenders-api](https://apify.com/devone-studio/ted-tenders-api)** — TED (Tenders Electronic Daily) EU public procurement search.
- **[pdf-to-text-api](https://apify.com/devone-studio/pdf-to-text-api)** — PDF to text + tables extraction via pdfplumber, no external calls.
- **[pubmed-articles-api](https://apify.com/devone-studio/pubmed-articles-api)** — NCBI PubMed biomedical literature with MeSH/DOI/year filters.
- **[federal-register-api](https://apify.com/devone-studio/federal-register-api)** — US federal agency rules, proposed rules, notices, presidential docs.
- **[sec-company-tickers](https://apify.com/devone-studio/sec-company-tickers)** — Resolve SEC CIK from ticker or company name (10,400+ issuers).
- **[sec-edgar-fulltext-search-api](https://apify.com/devone-studio/sec-edgar-fulltext-search-api)** — Full-text search across 35M+ SEC EDGAR filings and exhibits.
- **[sec-edgar-xbrl-frames-api](https://apify.com/devone-studio/sec-edgar-xbrl-frames-api)** — XBRL frames (Revenues, Assets, NetIncomeLoss) for ~6000 US issuers.
- **[cfpb-consumer-complaints-api](https://apify.com/devone-studio/cfpb-consumer-complaints-api)** — 18M+ US CFPB consumer complaints since 2011.
- **[nhtsa-safety-ratings-api](https://apify.com/devone-studio/nhtsa-safety-ratings-api)** — NHTSA NCAP 5-star vehicle safety ratings.
- **[eia-state-electricity-api](https://apify.com/devone-studio/eia-state-electricity-api)** — US state-level electricity generation and consumption, 1990-2025.

### Changelog

- **2026-10-12** — SEO metadata (seoTitle, seoDescription); README rewritten with real output sample, FAQ, cross-links.
- **2026-10-05** — Pricing switched to Apify pay-per-event (`$0.001` per dataset item).
- **2026-09-30** — Initial public release on the Apify Store.

# Actor input Schema

## `search_field` (type: `string`):

Field to search by.

## `search_value` (type: `string`):

Value to search for.

## `in_commercial_distribution_only` (type: `boolean`):

Only include devices currently in commercial distribution.

## `filter_is_otc` (type: `boolean`):

Only include OTC devices.

## `filter_is_rx` (type: `boolean`):

Only include prescription devices.

## `filter_is_single_use` (type: `boolean`):

Only include single-use devices.

## `filter_is_sterile` (type: `boolean`):

Only include sterile devices.

## `filter_has_serial` (type: `boolean`):

Only include devices with serial numbers.

## `filter_has_lot` (type: `boolean`):

Only include devices with lot/batch numbers.

## `sort_by` (type: `string`):

Sort field and direction.

## `max_results` (type: `integer`):

Maximum records to return (1-500).

## `include_derived` (type: `boolean`):

Include derived/computed fields.

## `include_metadata` (type: `boolean`):

Write run summary to METADATA key-value store.

## Actor input object example

```json
{
  "search_field": "brand_name",
  "search_value": "thermometer",
  "in_commercial_distribution_only": true,
  "filter_is_otc": false,
  "filter_is_rx": false,
  "filter_is_single_use": false,
  "filter_is_sterile": false,
  "filter_has_serial": false,
  "filter_has_lot": false,
  "sort_by": "default",
  "max_results": 25,
  "include_derived": true,
  "include_metadata": false
}
```

# Actor output Schema

## `results` (type: `string`):

All results of the run, as JSON from the default dataset.

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {};

// Run the Actor and wait for it to finish
const run = await client.actor("devone-studio/openfda-udi-api").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {}

# Run the Actor and wait for it to finish
run = client.actor("devone-studio/openfda-udi-api").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{}' |
apify call devone-studio/openfda-udi-api --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,devone-studio/openfda-udi-api"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/BblJ7AfCDjSFGCEtR/builds/RDsea2jBY8PdQi4w2/openapi.json