basixCOMPAK™ IN4918

GUDID 10884450544676

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 Catheter/overtube balloon inflator, single-use
Primary Device ID10884450544676
NIH Device Record Key91044503-0f92-49a4-8341-203b4b669085
Commercial Distribution StatusIn Commercial Distribution
Brand NamebasixCOMPAK™
Version Model Number00884450544679
Catalog NumberIN4918
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 Datetrue
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
GS100884450544679 [Primary]
GS110884450544676 [Package]
Contains: 00884450544679
Package: [5 Units]
In Commercial Distribution
GS120884450544673 [Package]
Package: [4 Units]
In Commercial Distribution

FDA Product Code

MAVSyringe, balloon inflation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-05
Device Publish Date2021-10-28

On-Brand Devices [basixCOMPAK™]

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1088445054467600884450544679
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1088445054459100884450544594

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