Kbmed

FDA UDI

Class II (US FDA UDI)

by KB Medical (group), Inc.

Identity

Trade Name: KBMED FDA UDI
Generic Name: Blood collection set, invasive FDA UDI
Device Name: Safety blood collection set, standard needle, 23G*3/4" with 12" tubing FDA UDI
Model / Reference: SBCN23-1 FDA UDI
Description: Safety blood collection set, standard needle, 23G*3/4" with 12" tubing FDA UDI

Identifiers

Primary DI / UDI-DI: 00850016172907 FDA UDI
510(k) Number: K232881 FDA UDI
FDA Product Code: JKA FDA UDI
GMDN Term: Blood collection set, invasive 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Blood collection set, invasive

Kbmed by KB Medical (group), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blood collection set, invasive.

MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
Custom Healthcare Systems Inc. — Manus Medical, LLC · Class II
MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class II
SOL-CARE™ Safety Blood Collection Needle — Sol-Millennium Medical, Inc. · Class II
SteriPath Gen2, 23G, BD — MAGNOLIA MEDICAL TECHNOLOGIES, INC. · Class II
RELI® — MYCO MEDICAL SUPPLIES INC. · Class II
Kawasumi — Jiangsu Caina Medical Co., Ltd · Class II
Custom Healthcare Systems Inc. — Manus Medical, LLC

Cleared under the same submission

K232881 also covers:

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: KB Medical (group), Inc.

Sources (1)

FDA UDI 433fb34d-0b98-4d90-a7b3-7fbb8f137924 34 fields · synced May 30, 2026