AccessGUDID - DEVICE: Ultra IABP Catheter Kit (00850012832485)

GUDID

Device Identifier (DI) Information

Brand Name: Ultra IABP Catheter Kit
Version or Model: IMU7F-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INSIGHTRA MEDICAL, INC.

Primary DI Number: 00850012832485
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 097664937 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSP	System, Balloon, Intra-Aortic And Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082746	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 7 French
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: b8ac6e10-5f7a-46d2-a103-d7f14cf7c0a2
Public Version Date: July 20, 2020
Public Version Number: 6
DI Record Publish Date: March 17, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00837654076439	5	00850012832485	2020-07-14	Not in Commercial Distribution	Shipper Box
00850012832492	5	00850012832485		In Commercial Distribution	Shipper Box Implant