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.
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{
"status": "Click RUN VALIDATION to execute on the Cloudflare edge..."
}
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.
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.
| Attribute | Specification | Requirement | Description |
|---|---|---|---|
| Primary DI Number | GTIN-14 / HIBC Primary / ISBT 128 | Mandatory | Unique master identifier assigned to the base package level |
| Issuing Agency | GS1 | HIBCC | ICCBBA | Mandatory | FDA-accredited issuing agency responsible for the symbology |
| Brand Name | 1-255 Characters | Mandatory | Commercial proprietary trade name of the medical device |
| Version / Model Number | 1-50 Characters | Conditional | Manufacturer internal catalog, reference, or model code |
| Premarket Number | 510(k) / PMA / De Novo | Conditional | FDA regulatory clearance number (e.g. K123456 or P123456) |
| GMDN Code / CTG | Global Medical Device Nomenclature | Mandatory | International standardized medical nomenclature classification |
| MRI Safety Status | Safe | Conditional | Unsafe | Mandatory | ASTM F2503 magnetic resonance imaging safety rating |
| Commercial Distribution | In Commercial Distribution | Off Market | Mandatory | Active 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:
{
"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
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.
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:
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View Format →HIBCC Medical Device Barcode Decoder & Modulo-43 Checksum Spec
Parse primary and secondary HIBCC medical barcodes with Modulo-43 check character validation.
View Format →ICCBBA ISBT 128 Medical Device & Cellular Therapy UDI Spec
Decode ICCBBA ISBT 128 medical and biologics identifiers for human cells, tissues, and cellular products.
View Format →FDA Global UDI Database (GUDID) Submission & Compliance Spec
Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA.
View Format →EU Medical Device Regulation (MDR 2017/745) EUDAMED UDI Spec
Verify Basic UDI-DI and UDI-DI data models for European EUDAMED regulatory compliance.
View Format →Medical Device Barcode Decoder — 2D DataMatrix, GS1-128 & Hospital Scanners
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View Format →EU EUDAMED Basic UDI-DI & UDI-DI Validation Architecture
Validate European Union MDR & IVDR Basic UDI-DI keys and packaging UDI-DI hierarchies for EUDAMED regulatory submission.
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