basixTau™ IN4T130

GUDID 10884450361396

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use
Primary Device ID10884450361396
NIH Device Record Keyd0800383-fab4-4267-afdc-64614d024cef
Commercial Distribution StatusIn Commercial Distribution
Brand NamebasixTau™
Version Model Number00884450361399
Catalog NumberIN4T130
Company DUNS184763290
Company NameMerit Medical Systems, Inc.
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450361399 [Primary]
GS110884450361396 [Package]
Contains: 00884450361399
Package: [5 Units]
In Commercial Distribution
GS120884450361393 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Product Code

PTMSyringe, Balloon Inflation, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2018-11-09

On-Brand Devices [basixTau™]

2088445040511000884450405116
1088445036378900884450363782
1088445036139600884450361399
2088445041344300884450413449

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.