gs1-healthcare
GS1 DataMatrix (GS1-DM)
Two-dimensional matrix code mandated globally for pharmaceutical unit-level traceability (FDA DSCSA, EU FMD). Encodes structured GS1 Application Identifiers.
Governing Specification: ISO/IEC 16022 / GS1 General Specifications Section 5.5
Data Format & Required Fields
Square or rectangular ECC 200 matrix encoding FNC1 in the first position to signal GS1 data format. Supports up to 2,335 alphanumeric characters or 3,116 numeric digits.
Allowed Character SetGS1 Application Identifiers with numeric, alphanumeric, and date payloads.
Payload Length Rule Between 14 and 200 characters
Required GS1 Structure Encodes standardized GS1 Application Identifiers (AIs). Unit-level and master packaging require primary identification (e.g. GTIN-14 or SSCC-18) combined with variable batch and serialization attributes for supply chain verification.
Check Digit / Checksum Rule Requires a verified modulo-10 check digit to prevent scanner misreads and data transposition errors.
Example Valid Format
(01)00300012345671(17)281231(10)LOT456(21)SER789Industry Guidance & Practical Applications
- Pharmaceutical unit-of-sale packages and bottles (DSCSA)
- Medical devices under FDA UDI regulations
- Clinical trial supplies and compounding pharmacy vials
Packaging & Scanning Notes: Crucial for DSCSA compliance: unit cartons must encode (01) GTIN-14, (21) Serial Number, (17) Expiration Date, and (10) Lot/Batch Number.
Symbol Constraints & Label Guidelines
- Requires camera-based image scanner (imager); cannot be read by linear laser scanners.
- Must observe a 1-module quiet zone around the complete perimeter.