K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector

GUDID 00646311551345

KAWASUMI LABORATORIES, INCORPORATED

Vascular port administration set
Primary Device ID00646311551345
NIH Device Record Key400b9a2f-964c-4def-8a8c-72eed5dc1a3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameK-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector
Version Model NumberPS01N21
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100646311551345 [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 Date2019-10-23
Device Publish Date2016-09-20

On-Brand Devices [K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector]

00646311551987PS04001
00646311551963PS02N21
00646311551956PS02N20
00646311551949PS02N01
00646311551932PS02N00
00646311551925PS02N91
00646311551918PS02N90
00646311551901PS01N90
00646311551895PS02Y21
00646311551888PS02Y20
00646311551871PS02Y01
00646311551864PS02Y00
00646311551857PS02Y91
00646311551840PS02Y90
00646311551833PS01Y21
00646311551826PS01Y20
00646311551819PS01Y01
00646311551802PS01Y00
00646311551796PS01Y91
00646311551789PS01Y90
00646311551710PS04021
00646311551703PS04020
00646311551680PS04000
00646311551673PS04091
00646311551666PS04090
00646311551475PS03090
00646311551345PS01N21
00646311551338PS03091
00646311551321PS03021
00646311551314PS03001
00646311551307PS03020
00646311551291PS03000
00646311551284PS01N01
00646311551277PS01N91
00646311551260PS01N20
00646311551253PS01N00

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