Identity
- Trade Name
- Straight Needle Phlebotomy Kit FDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Model / Reference
- K-INV-PHLEBOTOMY-SN/000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860009842274 FDA UDI
- FDA Product Code
- OFM FDA UDI
- GMDN Term
- Non-fixed blood collection needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-fixed blood collection needle
Straight Needle Phlebotomy Kit by Labcorp Genetics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-fixed blood collection needle.
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- 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
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
- Labcorp Genetics
Sources (1)
- FDA UDI 52c3c8ee-0317-4a32-82ac-fc2bdd65dab6 33 fields · synced May 30, 2026