IV ADMINISTRATION SET WITH .22 MICRON FILTER IV-025Y

GUDID 04987488098506

The IV Administration Set is a sterile, single use device used as a conduit for intravascular solution administration.

SB-KAWASUMI LABORATORIES, INC.

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Primary Device ID04987488098506
NIH Device Record Key3010f588-a9c2-42b7-b478-f94abfd75b98
Commercial Distribution StatusIn Commercial Distribution
Brand NameIV ADMINISTRATION SET WITH .22 MICRON FILTER
Version Model NumberIV-025Y
Catalog NumberIV-025Y
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 Identifiers

Device Issuing AgencyDevice ID
GS100646311490088 [Previous]
GS104987488098506 [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 Date2024-02-01
Device Publish Date2024-01-24

Devices Manufactured by SB-KAWASUMI LABORATORIES, INC.

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04987488102272 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102289 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102296 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102302 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
04987488102319 - PORT ACCESS INFUSION SET2024-04-22 Access needle with Infusion Set used for the delivery of medications to indwelling medication ports. Fluid administered through
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