EDGE ENGINE Sub-2ms Deterministic V8 Execution • Zero Data Retention Explore API Specs →
Latency: <2ms Edge Availability: 99.99% Standard: FDA AccessGUDID HL7 V8 Pure 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.

Official Regulatory Standard & Verification Protocol Authority: FDA AccessGUDID Database & IMDRF ↗

Quick Technical Summary: Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications. Implementation conforms to FDA 21 CFR 801.20 / EU MDR 2017/745.

Execution SLA
<2ms Edge (Cloudflare V8)
Governing Norm
FDA AccessGUDID HL7
Throughput Limit
512 KB / Payload
Data Privacy
100% In-Memory (Zero Store)

Specification & Structural Breakdown

FDA AccessGUDID serves as the authoritative public repository for medical device records mandated under 21 CFR § 801.40. Stanza 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
Interactive Edge Validator

Test FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification Live

Paste raw inputs up to 32KB and inspect deterministic parsed JSON in real-time across 330+ Cloudflare edge locations. Pure compute, zero cold-starts.

Launch Workbench →

Parsed JSON Response Model

The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:

HTTP 200 JSON Payload
{
  "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

Integrate this validator directly into your application using your production API key:

cURL
curl --request POST \
  --url "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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"
}'
Node.js (Fetch)
const response = await fetch("https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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);
Python (Requests)
import requests
import json

url = "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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())
Go
package main

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

func main() {
	url := "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/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))
}

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 Stanza query live FDA AccessGUDID records?

Yes. Stanza 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: