Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Model / Reference
- 00884450294406 FDA UDI
Identifiers
- Catalog Number
- K13-01162C FDA UDI
- Primary DI / UDI-DI
- 00884450294406 FDA UDI
- FDA Product Code
- PYB FDA UDI
- GMDN Term
- Procedural medication labelling set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Procedural medication labelling set
A comprehensive set of features and specifications for the Merit Medical device, designed for procedural medication labeling in perioperative and other procedural settings.
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 5e9c1174-53ca-4e5d-85fb-e334f9b9f5fa 33 fields · synced Jul 24, 2026