Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Peripheral intravenous catheterization support kit FDA UDI
- Device Name
- Kit Iv Start Chloraprep Frepp Tegaderm 2 3/8X2 3/4In 2X2In Non-Woven Gauze 1X18In Tourniquet 3/4X24In Transpore Tape Label Latex-Free Sterile MediChoice FDA UDI
- Model / Reference
- IVS1021 FDA UDI
- Description
- Kit Iv Start Chloraprep Frepp Tegaderm 2 3/8X2 3/4In 2X2In Non-Woven Gauze 1X18In Tourniquet 3/4X24In Transpore Tape Label Latex-Free Sterile MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632113383 FDA UDI
- 510(k) Number
- K923361 FDA UDI
- FDA Product Code
- LRS FDA UDI
- GMDN Term
- Peripheral intravenous catheterization support kit 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral intravenous catheterization support kit
MediChoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral intravenous catheterization support kit.
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Centurion — Centurion Medical Products · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- IV Start Kit w/Catheter, 18Ga — Altitude Technologies Inc. · Class II
- Motion Medical Distributing — Haslam Medical, Inc. · Class II
- Centurion — Centurion Medical Products · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 6597479f-a119-439b-a461-d132b9b98c13 35 fields · synced Jun 8, 2026