K-Shield Advantage Blood Drawing Kit BK-64A

GUDID 04987488104139

The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.

SB-KAWASUMI LABORATORIES, INC.

Phlebotomy kit
Primary Device ID04987488104139
NIH Device Record Key997e02ad-aa47-4e84-8a81-a4f145dcd349
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-Shield Advantage Blood Drawing Kit
Version Model NumberBK-64A
Catalog NumberBK-64A
Company DUNS690625850
Company NameSB-KAWASUMI LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com
Phone(813) 630-5554
Emailinfo@kawasumiamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100646311630040 [Previous]
GS104987488104139 [Primary]

FDA Product Code

KSBSet, Transfer (Blood/Plasma)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-01-01
Device Publish Date2024-12-24

Devices Manufactured by SB-KAWASUMI LABORATORIES, INC.

04987488104139 - K-Shield Advantage Blood Drawing Kit2025-01-01The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.
04987488104139 - K-Shield Advantage Blood Drawing Kit2025-01-01 The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blo
04987488104146 - INTERMITTENT INJECTION SITE2024-12-16 The product is a simple injection/aspiration port which will be sold by itself. It terminates in a male luer taper which can be
04987488102241 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102258 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102265 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102272 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102289 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102296 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through

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