Identity
- Trade Name
- ONE-CARE Safety Blood Collection Needles FDA UDI
- Generic Name
- Blood collection tube holder/needle FDA UDI
- Device Name
- ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' without Holders, Yellow, 48/bx, 50bx/cs FDA UDI
- Model / Reference
- 5022 ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' without Holders FDA UDI
- Description
- ONE-CARE Safety Blood Collection Needles 20G x 1 1/4'' without Holders, Yellow, 48/bx, 50bx/cs FDA UDI
Identifiers
- Catalog Number
- 5022 FDA UDI
- Primary DI / UDI-DI
- 00810008212868 FDA UDI
- 510(k) Number
- K172763 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 20 Gauge FDA UDILength — 1.25 Inch FDA UDI
Category: Blood collection tube holder/needle
ONE-CARE Safety Blood Collection Needles by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K172763 also covers:
- Henry Schein — HENRY SCHEIN, INC.
- HMG — Hartman Medical Group,LLC
- HMG — Hartman Medical Group,LLC
- HMG — Hartman Medical Group,LLC
- ULTRAFLO-V — Innovative Medical Technologies, Inc.
- ULTRAFLO-V — Innovative Medical Technologies, Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), Inc.
- KBMED — KB Medical (group), 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 |
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Manufacturer
- Manufacturer
- MediVena, LLC
Sources (1)
- FDA UDI b346c215-e6e0-4390-9fa3-86652bfa8639 38 fields · synced May 30, 2026