Ultra IABP Catheter Kit

GUDID 00837654076415

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.

Intra-aortic balloon catheter

• Primary Device ID: 00837654076415
• NIH Device Record Key: 6549282c-5bd3-4e86-8e5d-a441729e60ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra IABP Catheter Kit
• Version Model Number: IMU7F-35
• Company DUNS: 097664937
• Company Name: INSIGHTRA MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 949-215-1835
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com
• Phone: 931-919-2955
• Email: raqa@insightra.com

Device Dimensions

• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French
• Total Volume: 35 Milliliter
• Catheter Gauge: 7 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00837654076415 [Package]; Contains: 00850012832515; Package: [5 Units]; In Commercial Distribution
GS1	00850012832515 [Primary]
GS1	00850012832522 [Package]; Contains: 00850012832515; Package: Shipper Box Implant [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082746

FDA Product Code

• DSP: System, Balloon, Intra-Aortic And Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-07-20

On-Brand Devices [Ultra IABP Catheter Kit]

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