Sonostik Single Port ClearSafe Comfort Catheter Not Applicable

GUDID 00840155413672

Single Port ClearSafe Comfort, Closed Catheter 20G x 1”

MEDSOURCE INTERNATIONAL LLC

Central venous catheter inside-out introduction set
Primary Device ID00840155413672
NIH Device Record Keyd4adba75-b460-4d4b-9a5c-3931b234154a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonostik Single Port ClearSafe Comfort Catheter
Version Model NumberMS-872202
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
GS100840155413665 [Primary]
GS100840155413672 [Package]
Contains: 00840155413665
Package: Box [50 Units]
In Commercial Distribution
GS100840155413689 [Package]
Contains: 00840155413665
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 Date2022-10-04
Device Publish Date2022-09-26

On-Brand Devices [Sonostik Single Port ClearSafe Comfort Catheter]

00840155413672Single Port ClearSafe Comfort, Closed Catheter 20G x 1”
00840155413641Single Port ClearSafe Comfort, Closed Catheter 14G x 1.25”

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