FDA.reportPublic FDA data

CS300 Intra-Aortic Balloon Pump, Swedish, 220V

Primary DI
10607567112534
Brand
CS300 Intra-Aortic Balloon Pump, Swedish, 220V
Company
Datascope Corp.
Model
0998-00-3023-43
Catalog number
0998-00-3023-43
Device description
CS300 Intra-Aortic Balloon Pump, Swedish, 220V
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSPSystem, Balloon, Intra-Aortic And Control

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSPSystem, Balloon, Intra-Aortic And ControlCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063525000DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEMDatascope Corp.2007-01-05DSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607567112534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060756711253410607567112534

GMDN Terms#

Term, Definition table
TermDefinition
Intra-aortic balloon pumpAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure483 Millimeter of Mercury795 Millimeter of Mercury
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-627-8383customer.support@maquet.com

Regulatory Flags#

DUNS number
040874329
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607567114170Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB0884-00-0019-12U0884-00-0019-12U2024-02-20
10607567114194Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I0884-00-0019-13U0884-00-0019-13U2024-02-20
10607567114200Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc0884-00-0019-16U0884-00-0019-16U2024-02-20
10607567114217Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB0884-00-0019-17U0884-00-0019-17U2024-02-20
10607567114224Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs0884-00-0019-21U0884-00-0019-21U2024-02-20
10607567114231Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 70884-00-0019-22U0884-00-0019-22U2024-02-20
10607567114248Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr0884-00-0019-23U0884-00-0019-23U2024-02-20
10607567106656Reinforced Introducer Set for Linear 7.5Fr & Mega 7.5Fr0684-00-0403-050684-00-0403-052023-03-14
10607567106694Reinforced Introducer Set for Sensation 7Fr0684-00-0403-060684-00-0403-062023-03-14
10607567107943Reinforced Introducer Set for Sensation Plus & Mega 8Fr0684-00-0403-100684-00-0403-102023-03-14
10607567106632Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 25cc IAB0884-00-0019-120884-00-0019-122016-09-16
10607567106649Insertion Kit with 6” (15cm) Introducer for use with Linear 7.5Fr. 34cc & 40cc I0884-00-0019-130884-00-0019-132016-09-16
10607567106724Insertion Kit with 6” (15cm) Introducer for use with Sensation 7Fr. 34cc & 40cc0884-00-0019-160884-00-0019-162016-09-16
10607567107493Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB0884-00-0019-170884-00-0019-172016-09-16
10607567108025Insertion Kit with 6” (15cm) Introducer for use with MEGA 7.5Fr. 30 & 40cc IABs0884-00-0019-210884-00-0019-212016-09-16
10607567108599Insertion Kit with 8Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 8Fr0884-00-0019-230884-00-0019-232016-09-16
10607567108612Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 70884-00-0019-220884-00-0019-222016-09-16
10607567510996TigerPaw Pro Left Atrial Appendage Closure Device35mm7500010992020-11-18
10607567107301MEGA 8Fr. 50cc IAB0684-00-0498-010684-00-0498-012016-09-15
10607567107318MEGA 8Fr. 50cc IAB (with APA)0684-00-0498-020684-00-0498-022016-09-15

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