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

GS1 UDI Barcode Format & AI Parser Guide (GS1-128 & DataMatrix)

Parse GS1-128 linear barcodes and 2D DataMatrix medical device UDIs into structured DI/PI attributes in milliseconds. 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 21 CFR 801 / GS1 In-Memory Execution
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Official Standard & Validation Protocol Authority: FDA AccessGUDID Database & IMDRF ↗

Quick Summary: Parse GS1-128 linear barcodes and 2D DataMatrix medical device UDIs into structured DI/PI attributes in milliseconds. Validates strictly against FDA 21 CFR 801.20 / EU MDR 2017/745 with sub-5ms in-memory response times.

Latency
<2ms Edge
Standard
FDA 21 CFR 801 / GS1
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.

GS1 UDIs utilize Global Trade Item Numbers (GTIN) as the Device Identifier (AI 01) and standardized Application Identifiers for Production Identifiers.

AIData ElementFormatFDA / MDR Role
(01)GTIN-1414 digits numeric with Mod-10Primary UDI-DI
(17)Expiration DateYYMMDD (6 digits)UDI-PI Expiration
(10)Batch / Lot1-20 alphanumeric charactersUDI-PI Lot Number
(21)Serial Number1-20 alphanumeric charactersUDI-PI Serial Number
(11)Manufacturing DateYYMMDD (6 digits)UDI-PI Production Date

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
{
  "issuingAgency": "GS1",
  "di": "00884838012345",
  "pi": {
    "expirationDate": "2026-08-31",
    "lotNumber": "LOT7788",
    "serialNumber": "SN991823"
  }
}

Copy-Paste Integration Code (6 Languages)

Integrate GS1 UDI Barcode Format & AI Parser Guide (GS1-128 & DataMatrix) 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

Is GTIN check digit validation included?

Yes, the Modulo-10 check digit is verified on the GTIN-14 Device Identifier.

Related Medical Device UDI Barcode & AIDC Engine Formats

Explore sibling specifications and standards in the same developer cluster:

Complementary Enterprise APIs

Seamlessly orchestrate data pipelines across adjacent financial, regulatory, and supply-chain protocols:

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