Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Procedural medication labelling set FDA UDI
- Model / Reference
- 00884450172780 FDA UDI
Identifiers
- Catalog Number
- K13-00798B FDA UDI
- Primary DI / UDI-DI
- 00884450172780 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 collection of devices intended to provide clinical staff with a standardized method for labeling medications, medication containers, or other solutions in and outside the sterile field in perioperative and other procedural settings. This device is typically included in the minor surgical procedures tray.
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- NSCL25155 Custom Med Label Pack — XODUS MEDICAL, INC. · Class I
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 9aa5a7b5-f26d-46d7-bc85-70ef3883e6f0 33 fields · synced Jul 17, 2026