basixTOUCH™ IN8852

GUDID 20884450297395

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use
Primary Device ID20884450297395
NIH Device Record Key92df4875-9c5f-41ba-8cf9-155a4a4c93ba
Commercial Distribution StatusIn Commercial Distribution
Brand NamebasixTOUCH™
Version Model Number00884450297391
Catalog NumberIN8852
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
GS100884450297391 [Primary]
GS110884450297398 [Package]
Contains: 00884450297391
Package: [5 Units]
In Commercial Distribution
GS120884450297395 [Package]
Contains: 10884450297398
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 Number2
Public Version Date2020-05-06
Device Publish Date2019-08-09

On-Brand Devices [basixTOUCH™]

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1088445029296600884450292969
1088445029295900884450292952
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1088445010843400884450108437
2088445010834900884450108345
2088445036399100884450363997
2088445029739500884450297391
2088445044784400884450447840
1088445044785400884450447857
2088445062710900884450627105
2088445062130500884450621301
2088445062105300884450621059
1088445062103200884450621035
1088445062141400884450621417
2088445062132900884450621325
2088445062142800884450621424
1088445064194800884450641941
10884450621346C

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