Sonsotik Single Port Comfort Catheter Not Applicable

GUDID 00840155410084

Single Port ClearSafe Comfort, Closed Catheter 22G x 1”

MEDSOURCE INTERNATIONAL LLC

Central venous catheter inside-out introduction set
Primary Device ID00840155410084
NIH Device Record Keyfeeefd06-8bef-4c81-b8c5-46f0270552e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonsotik Single Port Comfort Catheter
Version Model NumberMS-87222
Catalog NumberNot Applicable
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840155410077 [Primary]
GS100840155410084 [Package]
Contains: 00840155410077
Package: Box [50 Units]
In Commercial Distribution
GS100840155410091 [Package]
Contains: 00840155410077
Package: Case [200 Units]
In Commercial Distribution

FDA Product Code

DYBIntroducer, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-27
Device Publish Date2021-09-17

On-Brand Devices [Sonsotik Single Port Comfort Catheter]

00840155410114Single Port ClearSafe Comfort, Closed Catheter 24G x 0.75”
00840155410084Single Port ClearSafe Comfort, Closed Catheter 22G x 1”
00840155410053Single Port ClearSafe Comfort, Closed Catheter 20G x 1.25”
00840155410022Single Port ClearSafe Comfort, Closed Catheter 18G x 1.25”
00840155409996Single Port ClearSafe Comfort, Closed Catheter 16G x 1.25”

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