basixTOUCH™ K05-02680

GUDID 10884450203214

Merit Medical Systems, Inc.

Catheter/overtube balloon inflator, single-use
Primary Device ID10884450203214
NIH Device Record Key9745560c-b3f4-4a62-b7b3-cd0029c7170c
Commercial Distribution StatusIn Commercial Distribution
Brand NamebasixTOUCH™
Version Model Number00884450203217
Catalog NumberK05-02680
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
GS100884450203217 [Primary]
GS110884450203214 [Package]
Contains: 00884450203217
Package: [5 Units]
In Commercial Distribution
GS120884450203211 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Product Code

OEQAngiography/angioplasty kit

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 Date2018-09-13

On-Brand Devices [basixTOUCH™]

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2088445062130500884450621301
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2088445062132900884450621325
2088445062142800884450621424
1088445064194800884450641941
10884450621346C

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