MedSource ET Tubes Not Applicable

GUDID 00840155412583

ET Tube, 4.5mm Cuffed

MEDSOURCE INTERNATIONAL LLC

Basic endotracheal tube, single-use
Primary Device ID00840155412583
NIH Device Record Key2c3b73af-cf6a-4560-b144-5acd79d362fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource ET Tubes
Version Model NumberMS-23245
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
GS100840155412576 [Primary]
GS100840155412583 [Package]
Contains: 00840155412576
Package: Box [10 Units]
In Commercial Distribution
GS100840155412590 [Package]
Contains: 00840155412576
Package: Case [100 Units]
In Commercial Distribution

FDA Product Code

BTRTube, Tracheal (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-02
Device Publish Date2022-04-22

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

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00840155413900 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 22Gx1
00840155413931 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 24Gx0.75
00840155413962 - MedSource Catheters2023-10-16 ClearSafe Comfort Closed System Dual Port 20Gx1
00840155413993 - MedSource Winged Catheters2023-10-16 ClearSafe Comfort I.V. Catheter, 14g x1.25 pur, winged
00840155414020 - MedSource Winged Catheters2023-10-16 ClearSafe Comfort I.V. Catheter, 16g x1.25 pur, winged

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