basixTau™ IN4T802

GUDID 20884450413443

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use
Primary Device ID20884450413443
NIH Device Record Key4865728b-cc6e-4ea6-831f-5cde62242e46
Commercial Distribution StatusIn Commercial Distribution
Brand NamebasixTau™
Version Model Number00884450413449
Catalog NumberIN4T802
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 Kittrue
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
GS100884450413449 [Primary]
GS110884450413446 [Package]
Contains: 00884450413449
Package: [5 Units]
In Commercial Distribution
GS120884450413443 [Package]
Contains: 10884450413446
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

On-Brand Devices [basixTau™]

2088445040511000884450405116
1088445036378900884450363782
1088445036139600884450361399
2088445041344300884450413449

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