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ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets FDA UDI
- Generic Name
- Luer-ended blood collection tube spike FDA UDI
- Device Name
- ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 25G x 0.75’’, Orange, 12'' Tube, Pre-Attached Holder, 25/bx, 20bx/cs FDA UDI
- Model / Reference
- 5060-H ONE-CARE PRESS & LOCK SBCWS 25G x 0.75’’, Pre-Attached Holder, 12'' Tube FDA UDI
- Description
- ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets 25G x 0.75’’, Orange, 12'' Tube, Pre-Attached Holder, 25/bx, 20bx/cs FDA UDI
Identifiers
- Catalog Number
- 5060-H FDA UDI
- Primary DI / UDI-DI
- 00810008212592 FDA UDI
- 510(k) Number
- K151991 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Luer-ended blood collection tube spike FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 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 — 25 Gauge FDA UDILength — 0.75 Inch FDA UDI
Category: Basic intravenous administration set, invasiveLuer-ended blood collection tube spike
ONE-CARE PRESS & LOCK Safety Blood Collection Wing Sets by MediVena, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Luer-ended blood collection tube spike.
- SURSHIELD — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
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- Medex — ICU MEDICAL, INC. · Class I
- Multi-Sampling Connector — Fresenius Kabi · Class I
- SURSHIELD — Terumo Medical Products (Hangzhou) Co., Ltd. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- Blood Culture Adapter — Sarstedt Aktiengesellschaft & Co.KG · Class II
Cleared under the same submission
K151991 also covers:
- 8943 SecureSafe Safety Blood Collection Set w/ Tube Holder, 21G, 3/4" Needle, 4/ — Dynarex Corp.
- 8944 SecureSafe Safety Blood Collection Set w/ Tube Holder, 23G, 3/4" Needle, 4/ — Dynarex Corp.
- 8945 SecureSafe Safety Blood Collection Set w/ Tube Holder, 25G, 3/4" Needle, 4/ — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- Blood Collection Set — Dynarex Corp.
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- CAINA — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical Co., Ltd
- SafeTPoint — Jiangsu Caina Medical Co., Ltd
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
- MediVena, LLC
Sources (1)
- FDA UDI 00cac73d-5abd-454a-90f0-50d1dedac595 37 fields · synced May 30, 2026