K-SHIELD ADVANTAGE WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER DBMA-25G

GUDID 04987488103385

The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter is used to access a patient's vein for blood sampling. The device incorporates an integral, active antineedle stick protector.

SB-KAWASUMI LABORATORIES, INC.

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Primary Device ID04987488103385
NIH Device Record Key3b453c72-b8e0-4651-9568-65599fb3d562
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD ADVANTAGE WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER
Version Model NumberDBMA-25G
Catalog NumberDBMA-25G
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
Phone(813)630-5554
Emailinfo@kawasumiamerica.com
Phone(813)630-5554
Emailinfo@kawasumiamerica.com
Phone(813)630-5554
Emailinfo@kawasumiamerica.com

Device Dimensions

Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge
Needle Gauge25 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100646311400254 [Previous]
GS104987488103385 [Primary]

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-10
Device Publish Date2024-04-02

On-Brand Devices [K-SHIELD ADVANTAGE WINGED COLLECTION SET WITH MULTIPLE SAMPLE LUER ADAPTER]

04987488103385The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter is used to access
04987488103279The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter is used to access
04987488103125The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter is used to access

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