IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec

GUDID 00646311490163

KAWASUMI LABORATORIES, INCORPORATED

Intravenous administration set
Primary Device ID00646311490163
NIH Device Record Keya15bf9a2-b7be-4f67-a123-577785c8ff7d
Commercial Distribution StatusIn Commercial Distribution
Brand NameIV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec
Version Model NumberIV-018N
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
GS100646311490163 [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

On-Brand Devices [IV ADMINISTRATION SET Primary Set with Backcheck Valve, Needleless Access Connec]

00646311490224IV-027N
00646311490217IV-026N
00646311490163IV-018N

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