IV ADD-ON FILTER ADMINISTRATION SET WITH 22 MICRON FILTER

GUDID 00646311490187

KAWASUMI LABORATORIES, INCORPORATED

Intravenous administration set
Primary Device ID00646311490187
NIH Device Record Key822d87d4-eef7-4de1-a5c7-bed0b71efca2
Commercial Distribution StatusIn Commercial Distribution
Brand NameIV ADD-ON FILTER ADMINISTRATION SET WITH 22 MICRON FILTER
Version Model NumberIV-F02Y
Company DUNS690625850
Company NameKAWASUMI LABORATORIES, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
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
GS100646311490187 [Primary]

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-11
Device Publish Date2016-09-20

Devices Manufactured by KAWASUMI LABORATORIES, INCORPORATED

00646311400292 - Rapid Access Kawasumi Multiple Sample Adapter with Pre-Attached Holder2020-02-10 The KAWASUMI Multiple Sample Adapter with Pre-attached Holder is a sterile, single use device consisting of a plastic holder wit
00646311490026 - IV ADMINISTRATION SET2019-12-11
00646311490040 - IV ADMINISTRATION SET2019-12-11
00646311490057 - IV ADMINISTRATION SET2019-12-11
00646311490064 - IV ADMINISTRATION SET2019-12-11
00646311490088 - IV ADMINISTRATION SET WITH 22 MICRON FILTER2019-12-11
00646311490095 - IV ADMINISTRATION SET with Needleless Access Connector2019-12-11
00646311490101 - IV ADMINISTRATION SET with Needleless Access Connector2019-12-11

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