# FDA AccessGUDID DI Commercial Distribution Status Monitor (`plym-actor-factory/us-fda-accessgudid-di-status-monitor`) Actor

Watch Primary Device Identifiers and emit typed DISTRIBUTION\_STATUS\_CHANGED / RECORD\_STATUS\_CHANGED / APPEARED / DROPPED events from NLM AccessGUDID. Not PPEF twin; not HC DPD twin; not 510(k) clearance twin; not openFDA recall twin.

- **URL**: https://apify.com/plym-actor-factory/us-fda-accessgudid-di-status-monitor.md
- **Developed by:** [Daniel Witney](https://apify.com/plym-actor-factory) (community)
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $20.00 / 1,000 gudid di status event delivereds

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

## FDA AccessGUDID Device Identifier Commercial Distribution Portfolio Event Monitor

Watch a book of **Primary Device Identifiers (DIs)** and emit typed events when **NLM AccessGUDID** shows a DI flipping **In Commercial Distribution ↔ Not in Commercial Distribution**, changing material **deviceRecordStatus / publicVersion**\*, **appearing**, or **dropping** from lookup.

**Not** CMS PPEF NPI twin (#27). **Not** Health Canada DPD DIN twin (#33). **Not** HC MDALL twin. **Not** FDA 510(k) clearance monitor twin. **Not** openFDA recall Actor (frozen). **Not** a flat UDI dump billed as rows.

### Coverage honesty

- **Source:** NLM AccessGUDID APIs — `https://accessgudid.nlm.nih.gov/api/v2/devices/lookup.json?di={DI}` (+ optional history). Default provenance **AccessGUDID**.
- **Keys:** **Primary DI** exact match after normalize (digits; leading zeros preserved).
- **Scope:** Commercial-distribution / record/version status only — do **not** claim recalls, adverse events, 510(k)/PMA outcomes, or Canadian MDALL licences.

### Events

| Event | When |
|-------|------|
| `DISTRIBUTION_STATUS_CHANGED` | `deviceCommDistributionStatus` / commercialDistributionStatus changed |
| `RECORD_STATUS_CHANGED` | deviceRecordStatus and/or publicVersion\* changed |
| `APPEARED` | Watched DI missing → present in AccessGUDID |
| `DROPPED` | Watched DI present → missing from AccessGUDID |
| `RUN_STATUS` | Non-billable health row every successful run |

First observation = **baseline only** (no product charge).

### Modes

- **`sourceMode=fixture`** (default): Store health → `RUN_STATUS` / `FIXTURE_HEALTH` only unless `emitFixtureDemoEvents=true`.
- **`sourceMode=live`**: AccessGUDID lookup per watched DI (**no paid key**).

### Pricing (Model A)

- `gudid-di-status-event-delivered` @ **$0.02**
- `apify-actor-start` @ **$0.00005**

### Legal

**GREEN** — AccessGUDID / FDA public device identification data. Cite NLM AccessGUDID + retrieval date. Do not claim patient-level UDI/PI surveillance.

### A1b wedge

Primary DI watchlist × scheduled AccessGUDID snapshot diff → typed distribution/record events only for the book. Same-job Store niche empty; wrong-job UDI dumps + 510(k) clearance monitor. See `opportunity/reports/phase3-a1b-next3-v16.md` (#2 PASS → build #45).

### Private

`isPublic` must remain **false** for this launch.

# Actor input Schema

## `primaryDis` (type: `array`):

Primary DI values to monitor via NLM AccessGUDID lookup. Exact match after normalize (digits; leading zeros preserved). Invalid entries skipped with no charge. Not a national UDI dump bill.

## `deviceIdentifiers` (type: `array`):

Optional alias for primaryDis — same Primary DI keys, merged into the watchlist.

## `signalGroups` (type: `array`):

Which change groups to evaluate: presence (APPEARED/DROPPED), distribution (commercialDistributionStatus), record (deviceRecordStatus / publicVersionStatus). Default: all.

## `maxRunSeconds` (type: `integer`):

Wall-clock budget for per-DI AccessGUDID lookups + diff.

## `maxEvents` (type: `integer`):

Stop after this many unique change events are delivered (does not include RUN\_STATUS).

## `resumeFromCheckpoint` (type: `boolean`):

If true, resume snapshots and seen event\_uids from the default Key-Value Store.

## `sourceMode` (type: `string`):

fixture = Store/CI health default. live = NLM AccessGUDID lookup/history (no paid key).

## `emitFixtureDemoEvents` (type: `boolean`):

When sourceMode=fixture, if true push fabricated change events from local fixtures. Default false so Store daily auto-tests never emit fake product events.

## `asOfHint` (type: `string`):

Optional YYYY-MM-DD as\_of label for events / RUN\_STATUS.

## `maxTotalChargeUsd` (type: `number`):

Optional soft budget hint for delivered change events.

## `accessGudidBaseUrl` (type: `string`):

Optional override for https://accessgudid.nlm.nih.gov/api/v2

## Actor input object example

```json
{
  "primaryDis": [
    "00848486000400",
    "00889024000123",
    "00000000000000"
  ],
  "signalGroups": [
    "presence",
    "distribution",
    "record"
  ],
  "maxRunSeconds": 90,
  "maxEvents": 500,
  "resumeFromCheckpoint": true,
  "sourceMode": "fixture",
  "emitFixtureDemoEvents": false
}
```

# Actor output Schema

## `OUTPUT` (type: `string`):

JSON summary: delivered, charged, runStatus, checkpoint, stats

# 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("plym-actor-factory/us-fda-accessgudid-di-status-monitor").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("plym-actor-factory/us-fda-accessgudid-di-status-monitor").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 plym-actor-factory/us-fda-accessgudid-di-status-monitor --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,plym-actor-factory/us-fda-accessgudid-di-status-monitor"
        }
    }
}
```

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/9YqriydaZ6Wy3M7mT/builds/sMDBAn2RFZNHDAvzS/openapi.json