TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES

Basic Information

• Brand Name: TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES
• Primary DI: 10607567111728
• Version / Model: 0684-00-0608
• Catalog Number: 0684-00-0608
• Company Name: DATASCOPE CORP.
• Labeler DUNS: 001660786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-12
• Public Version: 2
• Public Version Date: 2024-10-17
• Public Version Status: Update
• Public Device Record Key: a2838bff-0dab-4b53-9f27-549adf964d49

Device Description

TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIES

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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
Primary	10607567111728	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	7.5	French