MedSource Tracheostomy Mask

GUDID 00840155400368

Trach Mask Kit, Adult, All Dilu., U Conn

MEDSOURCE INTERNATIONAL LLC

Tracheostomy mask, aerosol
Primary Device ID00840155400368
NIH Device Record Keyf7ce163c-25fe-44f1-8f7e-00b3aa7dc338
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedSource Tracheostomy Mask
Version Model NumberMS-25210-U
Company DUNS041674552
Company NameMEDSOURCE INTERNATIONAL LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100840155400368 [Package]
Contains: 00840155411623
Package: Case [50 Units]
In Commercial Distribution
GS100840155411623 [Primary]

FDA Product Code

BYGMask, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-08
Device Publish Date2021-10-29

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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