K-SHIELD ADVANTAGE SMALL VEIN INFUSION SET D3KA-21G

GUDID 04987488102708

The K-Shield Advantage Small Vein Infusion Set with Antineedle Stick Protector is used to access a patient's vein for solution infusion. The device incorporates an integral active antineedle stick protector.

SB-KAWASUMI LABORATORIES, INC.

Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive Basic intravenous administration set, invasive
Primary Device ID04987488102708
NIH Device Record Key301d7a9e-061f-4ed0-a495-e91c2fb9dd01
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD ADVANTAGE SMALL VEIN INFUSION SET
Version Model NumberD3KA-21G
Catalog NumberD3KA-21G
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 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
GS100646311410468 [Previous]
GS104987488102708 [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 Date2024-04-22
Device Publish Date2024-04-12

On-Brand Devices [K-SHIELD ADVANTAGE SMALL VEIN INFUSION SET]

04987488103002The K-Shield Advantage Small Vein Infusion Set with Antineedle Stick Protector is used to access
04987488102968The K-Shield Advantage Small Vein Infusion Set with Antineedle Stick Protector is used to access
04987488102708The K-Shield Advantage Small Vein Infusion Set with Antineedle Stick Protector is used to access

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