PORT ACCESS INFUSION SET PI04091

GUDID 04987488103545

Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through the Port Access Infusion Set are those generally used in hospitals, and for chemotherapy.

SB-KAWASUMI LABORATORIES, INC.

Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set Vascular port administration set
Primary Device ID04987488103545
NIH Device Record Keydc5631d9-9ccc-4cba-9e38-01de1d11fdf2
Commercial Distribution StatusIn Commercial Distribution
Brand NamePORT ACCESS INFUSION SET
Version Model NumberPI04091
Catalog NumberPI04091
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 Latexfalse
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
GS100646311550089 [Previous]
GS104987488103545 [Primary]

FDA Product Code

FRNPump, Infusion

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 [PORT ACCESS INFUSION SET]

04987488103545Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102388Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102371Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102364Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102357Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102340Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102333Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102326Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102319Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102302Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102296Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102289Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102272Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102265Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102258Access needle with Infusion Set used for the delivery of medications to indwelling medication po
04987488102241Access needle with Infusion Set used for the delivery of medications to indwelling medication po

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