Identity
- Trade Name
- MEDLINE FDA UDI
- Generic Name
- Blood collection set, invasive FDA UDI
- Device Name
- BLOOD CULTURE, LUER LOCK ACCESS DEVICE FDA UDI
- Model / Reference
- BCLLAD FDA UDI
- Description
- BLOOD CULTURE, LUER LOCK ACCESS DEVICE FDA UDI
Identifiers
- Catalog Number
- BCLLAD FDA UDI
- Primary DI / UDI-DI
- 10193489189650 FDA UDI
- 510(k) Number
- K200027 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Blood collection set, invasive 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
Yes
FDA UDI
Category: Blood collection set, invasive
Medline by Medline Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood collection set, invasive.
- Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
- KBMED — KB Medical (group), Inc. · Class II
- MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
- SOL-CARE™ Safety Blood Collection Needle — Sol-Millennium Medical, Inc. · Class II
- SteriPath Gen2, 23G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
- RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
- Kawasumi — Jiangsu Caina Medical Co., Ltd · Class II
- Custom Healthcare Systems Inc. — Manus Medical, LLC
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.
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medline Industries, Inc.
Sources (1)
- FDA UDI c4ecca21-a205-4541-be94-2a8765f7f00a 37 fields · synced May 31, 2026