Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Model / Reference
- 00884450266878 FDA UDI
Identifiers
- Catalog Number
- K13-01828 FDA UDI
- Primary DI / UDI-DI
- 00884450266878 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 K13-01828 is a comprehensive procedural medication labeling set designed to provide clinical staff with a standardized method for labeling medications, medication containers, or other solutions in and outside of the sterile field. This single-use device features 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 ee9c8535-a1d8-4e95-94c0-d1a303e74f93 33 fields · synced Jul 26, 2026