K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder PBMH-25G

GUDID 04987488091217

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.

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Primary Device ID04987488091217
NIH Device Record Key6b011f16-d70b-41de-ad13-c87cb6c91916
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder
Version Model NumberPBMH-25G
Catalog NumberPBMH-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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS104987488091217 [Primary]

FDA Product Code

JKATubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-02-28
Device Publish Date2023-07-13

On-Brand Devices [K-SHIELD Zen Winged Blood Collection Set with Pre-attached Holder]

04987488091231K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-
04987488091224K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-
04987488091217K-SHIELD Zen is designed for accessing peripheral veins to collect blood. The Press Button anti-
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