Ultra IABP Catheter Kit

GUDID 00837654070956

The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.

INSIGHTRA MEDICAL, INC.

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Primary Device ID00837654070956
NIH Device Record Keyac7b0dda-52dc-4641-bbe4-e97c15ce1b7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra IABP Catheter Kit
Version Model NumberIMU7F-40
Company DUNS097664937
Company NameINSIGHTRA MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-215-1835
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com
Phone931-919-2955
Emailraqa@insightra.com

Device Dimensions

Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French
Total Volume40 Milliliter
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100837654070956 [Package]
Contains: 00850012832546
Package: Shipper Box [5 Units]
In Commercial Distribution
GS100850012832546 [Primary]
GS100850012832553 [Package]
Contains: 00850012832546
Package: Shipper Box Implant [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSPSystem, Balloon, Intra-Aortic And Control

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-07-20

On-Brand Devices [Ultra IABP Catheter Kit]

00837654070956The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic ball
00837654076415The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic ball
00837654076439The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic ball
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