basixTau™ IN4T530

GUDID 10884450363789

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use
Primary Device ID10884450363789
NIH Device Record Key596be314-3e55-4340-accd-1e133501390e
Commercial Distribution StatusIn Commercial Distribution
Brand NamebasixTau™
Version Model Number00884450363782
Catalog NumberIN4T530
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
GS100884450363782 [Primary]
GS110884450363789 [Package]
Contains: 00884450363782
Package: [5 Units]
In Commercial Distribution
GS120884450363786 [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 Date2018-12-13

On-Brand Devices [basixTau™]

2088445040511000884450405116
1088445036378900884450363782
1088445036139600884450361399
2088445041344300884450413449

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