Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Model / Reference
- 00884450521106 FDA UDI
Identifiers
- Catalog Number
- K13-04981 FDA UDI
- Primary DI / UDI-DI
- 00884450521106 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Procedural medication labelling set
Merit Medical's Procedural Medication Labelling Set is a single-use device designed to provide medical staff with a standardized method for labeling medications, medication containers, or other solutions in and outside of the sterile field. This device meets regulatory standards for minor surgical procedures and is suitable for use in various settings. It includes a permanent marking pen and various labels made of moisture-resistant plastic material.
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Authorization Coverage (1 country)
Regulatory Authorizations
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 8b962bc4-c9ad-4714-b5e0-8a95b61d7672 33 fields · synced Jul 29, 2026