K-SHIELD ADVANTAGE PORT ACCESS INFUSION SET PA01N91

GUDID 04987488102425

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.

SB-KAWASUMI LABORATORIES, INC.

Vascular port administration set
Primary Device ID04987488102425
NIH Device Record Key36c7eacf-e725-4f6c-b3ea-14ea1f29c32c
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD ADVANTAGE PORT ACCESS INFUSION SET
Version Model NumberPA01N91
Catalog NumberPA01N91
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 Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge
Needle Gauge19 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
GS100646311553127 [Previous]
GS104987488102425 [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 PORT ACCESS INFUSION SET]

04987488102456The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102692The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102661The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102630The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102531The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102524The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102517The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102470The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102463The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102449The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102432The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102425The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102418The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102401The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad
04987488102395The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to ad

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