Smith's Catheters Not Applicable

GUDID 00840155410978

Truesafe (PTFE Catheter), 24G x 0.75"

MEDSOURCE INTERNATIONAL LLC

Intravenous line recessed-needle connector
Primary Device ID00840155410978
NIH Device Record Keybb55ecaa-958d-46b6-89b6-2b5f8d5b3e04
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmith's Catheters
Version Model NumberSM-84424
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
GS100840155410961 [Primary]
GS100840155410978 [Package]
Contains: 00840155410961
Package: Box [50 Units]
In Commercial Distribution
GS100840155410985 [Package]
Contains: 00840155410961
Package: Case [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-23
Device Publish Date2021-08-13