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K-Shield Phlebotomy Set With Antineedle Stick Protector

FDA UDI

Class II (US FDA UDI)

by Sb-Kawasumi Laboratories, Inc.

Identity

Trade Name
K-SHIELD PHLEBOTOMY SET WITH ANTINEEDLE STICK PROTECTOR FDA UDI
Generic Name
Phlebotomy kit FDA UDI
Model / Reference
BO-1000 FDA UDI

Identifiers

Catalog Number
BO-1000 FDA UDI
Primary DI / UDI-DI
00646311620010 FDA UDI
FDA Product Code
LHI FDA UDI
GMDN Term
Phlebotomy kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5440 FDA UDI
Commercial Distribution
Not 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

K-Shield Phlebotomy Set With Antineedle Stick Protector by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sb-Kawasumi Laboratories, Inc.

Sources (1)

  • FDA UDI c35389f9-0a00-494a-b31f-ac7d40e70b03 35 fields · synced May 30, 2026