Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Model / Reference
- 00884450371657 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450371657 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
Yes
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
A comprehensive procedural medication labeling set designed for use in perioperative and other procedural settings. This single-use device is intended to provide a standardized method for labeling medications, medication containers, or solutions in and outside of the sterile field. The labels are made of moisture-resistant plastic material and feature standard medication/drug/solution text.
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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 09d43dea-c2c0-49bb-a0c9-73c68bc5f0ba 32 fields · synced Jul 19, 2026