Identity
- Trade Name
- BLUDRAW FDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Device Name
- Safety Multi-Drawing Needles 21G x 1 1/4" FDA UDI
- Model / Reference
- 21G x 1 1/4" FDA UDI
- Description
- Safety Multi-Drawing Needles 21G x 1 1/4" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06958697610894 FDA UDI
- 510(k) Number
- K220900 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Non-fixed blood collection 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
No
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
Bludraw by Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd — 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
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
- Anhui Hongyu Wuzhou Medical Manufacturer Co Ltd
Sources (1)
- FDA UDI d4c5380b-c705-4661-9f00-2d241a508371 34 fields · synced May 30, 2026