Identity
- Trade Name
- Blood Collection Set FDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Model / Reference
- 8950 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784895024 FDA UDI
- 510(k) Number
- K151991 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Non-fixed blood collection needle 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
Category: Non-fixed blood collection needle
Blood Collection Set by Dynarex Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-fixed blood collection needle.
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- IMPROSAFE® Multi Sample Needle (Flashback) — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Vacuette — Greiner Bio-One GmbH · Class II
- IMPROVACUTER® Blood Collection Set — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- Marketlab Inc — MARKETLAB INC. · Class II
- IMPROSAFE® Multi Sample Needle — Guangzhou Improve Medical Instruments Co., Ltd. · Class II
- IMPROSAFE® Blood Collection Set with Pre-Attached Holder — Guangzhou Improve Medical Instruments Co., Ltd. · 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.
- 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
- 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 |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 2f734c76-0af3-46dc-822d-23b3012120df 33 fields · synced May 29, 2026