Smith's Catheters Not Applicable

GUDID 00840155411210

Truesafe Comfort (PUR Catheter), 20G x 1.88"

MEDSOURCE INTERNATIONAL LLC

Intravenous line recessed-needle connector
Primary Device ID00840155411210
NIH Device Record Key19f102eb-3fe7-404b-9b0e-e4429d1c2234
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmith's Catheters
Version Model NumberSM-84320
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
GS100840155411203 [Primary]
GS100840155411210 [Package]
Contains: 00840155411203
Package: Box [50 Units]
In Commercial Distribution
GS100840155411227 [Package]
Contains: 00840155411203
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