Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Model / Reference
- 00884450329832 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884450329832 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 clinical staff to standardize the labeling of medications, solutions, and other substances in sterile field settings. The device is a single-use product that includes a permanent marking pen, various labels made of moisture-resistant plastic material, and additional text fields.
Similar devices
Also classified as Procedural medication labelling set.
- CL22322 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
- Centurion — Centurion Medical Products · Class I
- NSCL24297 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
- CL24159 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
- NSCL21654 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
- CL22017 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
- CL24584 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
- NSCL25155 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 8efe7ee2-d194-4b7d-bc70-c44be533eec0 32 fields · synced Jul 11, 2026