K-SHIELD ADVANTAGE WINGED BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER DBMH-23G

GUDID 04987488103477

The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached Holder 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 ID04987488103477
NIH Device Record Key3f8ece08-a62f-4819-9063-3a431372632b
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD ADVANTAGE WINGED BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Version Model NumberDBMH-23G
Catalog NumberDBMH-23G
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 Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge
Needle Gauge23 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100646311400278 [Previous]
GS104987488103477 [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 BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER]

04987488103538The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached
04987488103477The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached
04987488103453The K-Shield Advantage Winged Collection Set with Multiple Sample Luer Adapter with Pre-Attached
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