Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Contrast medium injection system administration set FDA UDI
- Model / Reference
- 00884450259979 FDA UDI
Identifiers
- Catalog Number
- K09-11362B FDA UDI
- Primary DI / UDI-DI
- 00884450259979 FDA UDI
- FDA Product Code
- OEZ FDA UDI
- GMDN Term
- Contrast medium injection system administration set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1200 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: Contrast medium injection system administration set
A comprehensive and accurate description of the Merit Medical Contrasting medium injection system administration set. This medical device is designed for safe and effective use in healthcare settings.
Similar devices
Also classified as Contrast medium injection system administration set.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 2d7b1329-8855-4c94-85ab-961cc90d89d0 33 fields · synced Jul 20, 2026