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FDA 21 CFR 801.20 / EU MDR 2017/745 <2ms Edge Edge Compute

FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification

Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications. This specification documents the exact field layout, checksum rules, and validation behavior so your integration matches FDA 21 CFR 801.20 / EU MDR 2017/745 without reading the source standard.

Latency: <2ms Edge Availability: 99.99% Standard: FDA AccessGUDID HL7 In-Memory Execution
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⚡ Live FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification Interactive Workbench

Test real-time validation and schema parsing for FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification directly in your browser. Runs in sub-5ms with zero setup.

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input.txt 0 B
output.json demo-ready
Status: Ready
{
  "status": "Click RUN VALIDATION to execute on the Cloudflare edge..."
}
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LLM / MCP
Prompt-Ready Specification for AI Agents llms.txt
Structured format rules and schemas optimized for LLM coding agents and Model Context Protocol tooling.
Raw .md
Official Standard & Validation Protocol Authority: FDA AccessGUDID Database & IMDRF ↗

Quick Summary: Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications. Validates strictly against FDA 21 CFR 801.20 / EU MDR 2017/745 with sub-5ms in-memory response times.

Latency
<2ms Edge
Standard
FDA AccessGUDID HL7
Version
Max Payload
512 KB
Privacy
In-Memory (0 bytes stored)

Specification & Structural Breakdown

Technical Summary: Validates strictly against FDA 21 CFR 801.20 / EU MDR 2017/745. Payloads are parsed in memory and return clean, typed JSON in milliseconds with zero data logged.

FDA AccessGUDID serves as the authoritative public repository for medical device records mandated under 21 CFR § 801.40. StanzaAPI provides instant validation of Primary DI syntax and attribute verification.

AttributeSpecificationRequirementDescription
Primary DI NumberGTIN-14 / HIBC Primary / ISBT 128MandatoryUnique master identifier assigned to the base package level
Issuing AgencyGS1 | HIBCC | ICCBBAMandatoryFDA-accredited issuing agency responsible for the symbology
Brand Name1-255 CharactersMandatoryCommercial proprietary trade name of the medical device
Version / Model Number1-50 CharactersConditionalManufacturer internal catalog, reference, or model code
Premarket Number510(k) / PMA / De NovoConditionalFDA regulatory clearance number (e.g. K123456 or P123456)
GMDN Code / CTGGlobal Medical Device NomenclatureMandatoryInternational standardized medical nomenclature classification
MRI Safety StatusSafe | Conditional | UnsafeMandatoryASTM F2503 magnetic resonance imaging safety rating
Commercial DistributionIn Commercial Distribution | Off MarketMandatoryActive lifecycle distribution state in the United States

Parsed JSON Response Model

The edge microservice transforms input payloads into strongly-typed hierarchical JSON envelopes with sub-5ms latency:

HTTP 200 JSON Response Envelope
{
  "accessgudidStatus": "VERIFIED",
  "primaryDi": "00884838012345",
  "issuingAgency": "GS1",
  "brandName": "PrecisionPulse Titanium Implantable Lead",
  "modelNumber": "PL-4500X",
  "premarketNumber": "K241289",
  "mriSafety": "MR Conditional",
  "commercialDistribution": "In Commercial Distribution"
}

Copy-Paste Integration Code (6 Languages)

Integrate FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification directly into your production application with native, zero-dependency code snippets in cURL, Node.js, Python, Go, C#, and a ready-to-paste Claude prompt. Get a free API key → (no credit card required):

curl --request POST \
  --url "https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode" \
  --header "Content-Type: application/json" \
  --header "x-api-key: YOUR_API_KEY" \
  --data '{
  "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}'
const response = await fetch("https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode", {
  method: "POST",
  headers: {
    "Content-Type": "application/json",
    "x-api-key": process.env.API_KEY || "YOUR_API_KEY"
  },
  body: JSON.stringify({
  "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
})
});

const data = await response.json();
console.log(data);
import requests
import json

url = "https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode"
headers = {
    "Content-Type": "application/json",
    "x-api-key": "YOUR_API_KEY"
}
payload = {
    "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}

response = requests.post(url, json=payload, headers=headers)
print(response.json())
package main

import (
	"bytes"
	"fmt"
	"io"
	"net/http"
	"os"
)

func main() {
	url := "https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode"
	payload := []byte(`{"udi":"(01)00884838012345(17)260831(10)LOT7788(21)SN991823"}`)

	req, _ := http.NewRequest("POST", url, bytes.NewBuffer(payload))
	req.Header.Add("Content-Type", "application/json")
	req.Header.Add("x-api-key", os.Getenv("API_KEY"))

	res, err := http.DefaultClient.Do(req)
	if err != nil {
		panic(err)
	}
	defer res.Body.Close()
	body, _ := io.ReadAll(res.Body)
	fmt.Println(string(body))
}
using System;
using System.Net.Http;
using System.Text;
using System.Threading.Tasks;

class Program
{
    static async Task Main()
    {
        using var client = new HttpClient();
        client.DefaultRequestHeaders.Add("x-api-key", Environment.GetEnvironmentVariable("API_KEY") ?? "YOUR_API_KEY");

        var json = @"{""udi"":""(01)00884838012345(17)260831(10)LOT7788(21)SN991823""}";
        var payload = new StringContent(json, Encoding.UTF8, "application/json");

        var response = await client.PostAsync("https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode", payload);
        var content = await response.Content.ReadAsStringAsync();
        Console.WriteLine(content);
    }
}
Integrate the StanzaAPI udi-decoder micro-API.

Endpoint: POST https://api.stanzaapi.com/udi-decoder/api/v1/udi/decode
Auth header: x-api-key: YOUR_API_KEY
Content-Type: application/json
Request body:
{
  "udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}

Rules:
- Send the request with a 2-second timeout.
- Parse the standard envelope { success, data, meta: { latency_ms, version } }.
- On failure, read { success: false, error, code } and branch on the code.
- Do not retry 4xx responses; surface the error code to the caller.
- Treat invalid-but-well-formed payloads as HTTP 200 with data.valid === false.

Frequently Asked Questions & Technical Notes

What is the format of an FDA AccessGUDID Primary DI?

Primary DIs must strictly conform to GS1 GTIN-14 (14 digits numeric with Modulo-10 check digit), HIBCC (+LIC followed by product code and Mod-43), or ICCBBA ISBT 128.

Can StanzaAPI query live FDA AccessGUDID records?

Yes. StanzaAPI provides an optional Ultra/Enterprise live GUDID lookup bridge (/api/v1/udi/live) that resolves real-time FDA catalog records with edge-cached sub-10ms response times.

Related Medical Device UDI Barcode & AIDC Engine Formats

Explore sibling specifications and standards in the same developer cluster:

Complementary Enterprise APIs

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All Medical Device UDI Barcode & AIDC Engine Formats & Specifications (8) Directory Index ↓
GS1 UDI Barcode Format & AI Parser Guide (GS1-128 & DataMatrix) HIBCC Medical Device Barcode Decoder & Modulo-43 Checksum Spec ICCBBA ISBT 128 Medical Device & Cellular Therapy UDI Spec FDA Global UDI Database (GUDID) Submission & Compliance Spec EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI Spec FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification Medical Device Barcode Decoder — 2D DataMatrix, GS1-128 & Hospital Scanners EU EUDAMED Basic UDI-DI & UDI-DI Validation Architecture