CS100 Intra-Aortic Balloon Pump, Portuguese, 220V

Basic Information

• Brand Name: CS100 Intra-Aortic Balloon Pump, Portuguese, 220V
• Primary DI: 10607567107691
• Version / Model: 0998-00-3013-68
• Catalog Number: 0998-00-3013-68
• Company Name: Datascope Corp.
• Labeler DUNS: 040874329
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 5
• Public Version Date: 2023-03-02
• Public Version Status: Update
• Public Device Record Key: 6826662c-1666-4a00-b7d0-d433ed08c58b
• Distribution End Date: 2016-12-31

Device Description

CS100 Intra-Aortic Balloon Pump, Portuguese, 220V

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
36340	Intra-aortic balloon pump	An electrically-powered device intended to inflate/deflate the balloon of an intra-aortic balloon catheter (not included) to assist cardiac function. The device monitors the patient’s electrocardiogram (ECG) and blood pressure to inflate/deflate the balloon in synchrony with the cardiac cycle, so that the balloon inflates after a cardiac contraction to increase perfusion of the coronary arteries and deflates before the next contraction to avoid obstructing aortic outflow. The device typically includes a main unit which incorporates a helium cylinder for balloon inflation/deflation, a screen, and controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10607567107691	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031636	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 483 – 760 Millimeter of Mercury
• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius