AccessGUDID - DEVICE: MEGA 8Fr. 50cc IAB (with APA) (10607567107318)

GUDID

Device Identifier (DI) Information

Brand Name: MEGA 8Fr. 50cc IAB (with APA)
Version or Model: 0684-00-0498-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0684-00-0498-02
Company Name: DATASCOPE CORP.

Primary DI Number: 10607567107318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001660786 *Terms of Use

Device Description: MEGA 8Fr. 50cc IAB (with APA)

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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 [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: d12ae095-4168-4441-bd20-0b0b1e6d817a
Public Version Date: December 09, 2024
Public Version Number: 4
DI Record Publish Date: September 15, 2016