Identity
- Trade Name
- KBMED FDA UDI
- Generic Name
- Non-fixed blood collection needle FDA UDI
- Device Name
- Safety Multi-sample Needle, 22G*1-1/4", box of 48pcs FDA UDI
- Model / Reference
- SBCN22-3 FDA UDI
- Description
- Safety Multi-sample Needle, 22G*1-1/4", box of 48pcs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810100050214 FDA UDI
- 510(k) Number
- K172763 FDA UDI
- FDA Product Code
- JKA FDA UDIFMI FDA UDI
- GMDN Term
- Non-fixed blood collection needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI880.5570 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
No
FDA UDI
Category: Non-fixed blood collection needle
Kbmed by KB Medical (group), Inc. — 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
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
- KB Medical (group), Inc.
Sources (1)
- FDA UDI 87821a8a-acfd-49dc-8200-c3d1762c50f8 34 fields · synced Jun 8, 2026