Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Blood collection tube holder/needle FDA UDI
- Device Name
- Leur Adapter Standard Standard Polypropylene Green Single Use CA/1000 Not made with Natural Rubber Latex MediChoice FDA UDI
- Model / Reference
- 50012 FDA UDI
- Description
- Leur Adapter Standard Standard Polypropylene Green Single Use CA/1000 Not made with Natural Rubber Latex MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632401336 FDA UDI
- 510(k) Number
- K200027 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection tube holder/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 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
No
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: Blood collection tube holder/needle
MediChoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K200027 also covers:
- caina — Jiangsu Caina Medical Co., Ltd
- caina — Jiangsu Caina Medical Co., Ltd
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- MediChoice — OWENS & MINOR DISTRIBUTION, INC.
- Resilient Medical Solutions — Resilient Medical Solutions, LLC
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
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 65c87ec5-b2cc-4d9e-811f-c42d9a6883b6 34 fields · synced Jun 8, 2026