FDA.reportPublic FDA data

CARDIOSAVE BATTERY CHARGING STATION

Primary DI
10607567111964
Brand
CARDIOSAVE BATTERY CHARGING STATION
Company
Datascope Corp.
Model
0998-00-0802
Catalog number
0998-00-0802
Device description
CARDIOSAVE BATTERY CHARGING STATION
Published
2016-09-21
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
K112372000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112372000CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCardiac Assist, Maquet Cardiovascular, LLC2011-09-15DSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607567111964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060756711196410607567111964

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure483 Millimeter of Mercury795 Millimeter of Mercury
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902172843ARROWTELEFLEX INCORPORATEDDSP2026-08-01
10801902216813ARROWTELEFLEX INCORPORATEDDSP2026-07-27
10801902223729ARROWTELEFLEX INCORPORATEDDSP2025-10-02
10801902223859ARROWTELEFLEX INCORPORATEDDSP2025-10-02
10801902219609ARROWTELEFLEX INCORPORATEDDSP2025-04-30
20801902219606ARROWTELEFLEX INCORPORATEDDSP2025-04-30
10607567113432CARDIOSAVE HYBRID, 3.1 EDITIONDatascope Corp.DSP2024-09-09
10607567113449CARDIOSAVE RESCUE, 3.1 EDITIONDatascope Corp.DSP2024-09-09
10607567114187"CARDIOSAVE HYBRID - TYPE ""N"" PLUG"Datascope Corp.DSP2024-09-09
10607567107585YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KITDATASCOPE CORP.DSP2024-08-12
10607567107592YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)DATASCOPE CORP.DSP2024-08-12
10607567107608YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KITDATASCOPE CORP.DSP2024-08-12
10607567107639YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)DATASCOPE CORP.DSP2024-08-12
10607567111537Catheter Extender for Yamato Plus IABs - 10 PackDATASCOPE CORP.DSP2024-08-12
10607567111711TRANS-RAY PLUS 7.5Fr 35cc IAB WITH ACCESSORIESDATASCOPE CORP.DSP2024-08-12
10607567111728TRANS-RAY PLUS 7.5Fr 40cc IAB WITH ACCESSORIESDATASCOPE CORP.DSP2024-08-12
10607567104713CABLE,EXTERNAL SIGNAL,IABPDatascope Corp.DSP2024-07-26
10607567112817CARDIOSAVE LI-ION SINGLE BTTY TRANSPORTDatascope Corp.DSP2024-07-26
10607567113760CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCEDatascope Corp.DSP2024-07-26
10607567113777CABLE,LOW LEVEL OUTPUT,PHILIPSDatascope Corp.DSP2024-07-26
10607567113784CABLE,LOW LEVEL OUTPUT,GEDatascope Corp.DSP2024-07-26
10607567113807"CABLE,INTERFACE,1/4-1/4"",30'"Datascope Corp.DSP2024-07-26
10607567113814"CABLE, INTERFACE .25"" PLUG TO .25"" PLUG 30"Datascope Corp.DSP2024-07-26
10607567113821CABLE, INTERFACE 1/4” PLUG TO 1/8” PLUG,Datascope Corp.DSP2024-07-26
10607567113845CABLE INTERFACE 1/4” BIFURCATED PLUGS TO 6Datascope Corp.DSP2024-07-26
10607567113852"CABLE INTERFACE, 1/4"" PLUG TO TT-253 PLU"Datascope Corp.DSP2024-07-26
10607567113869AC PWR CORD,NEMA 5-15P TYPE BDatascope Corp.DSP2024-07-26
10607567113975COVER,CARDIOSAVE RAINDatascope Corp.DSP2024-07-26
10607567114262CABLE,LOW LEV OUTPUT,DATASCOPEDatascope Corp.DSP2024-07-26
10607567114279CABLE,LL OUTPUT,UN-TERMINATEDDatascope Corp.DSP2024-07-26