Identity
- Trade Name
- Merit Medical® FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Model / Reference
- 00884450178690 FDA UDI
Identifiers
- Catalog Number
- K08-00759 FDA UDI
- Primary DI / UDI-DI
- 00884450178690 FDA UDI
- FDA Product Code
- OJA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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: Basic intravenous administration set, noninvasive
A comprehensive intravenous administration set designed for safe and efficient fluid collection from an IV bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration, with some types intended for enteral feeding applications. It's a single-use device that includes tubing, connectors, chambers, and clamps.
Similar devices
Also classified as Basic intravenous administration set, noninvasive.
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- IMED — BQ PLUS MEDICAL CO., LTD. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- Kew Medical — DOUGLAS MEDICAL PRODUCTS, INC · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merit Medical Systems, Inc.
Sources (1)
- FDA UDI 39b811ad-194d-4ce6-8d15-6fd3f6511c57 33 fields · synced Jul 22, 2026