Identity
- Trade Name
- Trinity Sterile, Inc. FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- IV START KIT FDA UDI
- Model / Reference
- 50848 FDA UDI
- Description
- IV START KIT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841767106485 FDA UDI
- 510(k) Number
- K923361 FDA UDI
- FDA Product Code
- LRS FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 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
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Basic intravenous administration set, noninvasive
The IV Start Kit from Trinity Sterile, Inc. is a comprehensive and single-use intravenous administration set designed for general hospital use. The kit includes a sterile bag/bottle, tubing, connectors, chambers, and clamps that can be used to conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula.
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Also classified as Basic intravenous administration set, noninvasive.
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- Kew Medical — DOUGLAS MEDICAL PRODUCTS, INC · Class II
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Cleared under the same submission
K923361 also covers:
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
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 |
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Manufacturer
- Manufacturer
- Trinity Sterile, Inc.
Sources (1)
- FDA UDI 085b4ac7-7684-4061-b3e8-0b65059c6af4 34 fields · synced Jul 5, 2026