Ultra IABP Catheter Kit

Basic Information

• Brand Name: Ultra IABP Catheter Kit
• Primary DI: 00850012832485
• Version / Model: IMU7F-30
• Company Name: INSIGHTRA MEDICAL, INC.
• Labeler DUNS: 097664937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-03-17
• Public Version: 6
• Public Version Date: 2020-07-20
• Public Version Status: Update
• Public Device Record Key: b8ac6e10-5f7a-46d2-a103-d7f14cf7c0a2

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	870.3535	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34919	Intra-aortic balloon catheter	A flexible, balloon-tipped, tube that is placed in the aorta distal to the aortic valve to augment the heart's pumping capability. It is typically introduced percutaneously via one of the femoral arteries and advanced to the descending thoracic aorta using fluoroscopic imaging guidance. Once positioned, an external pump alternately inflates and deflates the balloon in a cycle counter to the cardiac cycle (counter pulsation), facilitating ejection during systole and limits regurgitation during diastole. It is used to treat several cardiovascular conditions, e.g., after open-heart surgery, cardiogenic shock, intractable angina, or to reduce myocardial conditions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00837654076439	GS1	Shipper Box	5	Not in Commercial Distribution	2020-07-14
Primary	00850012832485	GS1
Package	00850012832492	GS1	Shipper Box Implant	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K082746	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	7	French
Total Volume	30	Milliliter