K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter

GUDID 04987488091187

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.

SB-KAWASUMI LABORATORIES, INC.

Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive Blood collection set, invasive
Primary Device ID04987488091187
NIH Device Record Keyb2ff0cf0-4658-4f36-9e9e-f96c914f0c02
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter
Version Model NumberPBMA-21G
Company DUNS690625850
Company NameSB-KAWASUMI LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
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
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
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 Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge
Needle Gauge21 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS104987488091187 [Primary]

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-06
Device Publish Date2023-06-28

On-Brand Devices [K-SHIELD Zen Winged Blood Collection Set with Multiple Sample Luer Adapter]

04987488091200K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-
04987488091194K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-
04987488091187K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.