K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder

FDA UDI

Class II (US FDA UDI)

by Sb-Kawasumi Laboratories, Inc.

Identity

Trade Name: K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder FDA UDI
Generic Name: Blood collection set, invasive FDA UDI
Device Name: K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries. FDA UDI
Model / Reference: PBMH-23G FDA UDI
Description: K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-needle stick protector is an integral safety device intended to minimize accidental needlestick injuries. FDA UDI

Identifiers

Catalog Number: PBMH-23G FDA UDI
Primary DI / UDI-DI: 04987488091224 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

Yes

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 23 Gauge FDA UDI

Category: Blood collection set, invasive

K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID

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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: Sb-Kawasumi Laboratories, Inc.

Sources (1)

FDA UDI 5e7deaa3-aabe-4a93-bab6-5bec2c9e5567 36 fields · synced May 30, 2026