FDA.reportPublic FDA data

CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE

Primary DI
10607567113760
Brand
CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE
Company
Datascope Corp.
Model
0012-00-1815
Catalog number
0012-00-1815
Device description
CABLE ASSEMBLY, BLOOD PRESSURE TRANSDUCE
Published
2024-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607567113760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060756711376010607567113760

GMDN Terms#

Term, Definition table
TermDefinition
Invasive blood pressure transducer setA collection of devices that includes tubing, a pressure transducer(s), and other items [e.g., connectors, stopcock(s), clamps and filters] intended to be used for an invasive blood pressure measurement. This set will typically connect directly to the applied invasive catheter and the transducer will provide the electrical signals for display by a patient monitoring system. This device will have physical characteristics appropriate for preserving, to the extent possible, the waveform and fidelity of the measured pressure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
040874329
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
10607567107479Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only0684-00-0510-020684-00-0510-022016-09-23
10607567107516Catheter Extenders for 50cc IAB’s 0684-00-05260684-00-05262016-09-14
10607567108001MEGA 8Fr. 50cc IAB (with Statlock)0684-00-0296-010684-00-0296-012016-09-15
10607567108018MEGA 8Fr. 50cc IAB (with Statlock & APA)0684-00-0296-020684-00-0296-022016-09-15
10607567108063SENSATION PLUS 7.5Fr. 40cc IAB & Accessories0684-00-0568-010684-00-0568-012016-09-15
10607567108605SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)0684-00-0576-010684-00-0576-012016-09-15
10607567109381Sensation Plus 8Fr 50cc IAB With Accessories (w/Pressure Tubes, No Stylet, w/o S0684-00-0576-050684-00-0576-052016-09-15
10607567109411MEGA 8Fr. 50cc IAB (W/O Statlock)0684-00-0296-030684-00-0296-032016-09-15
10607567109428Sensation Plus 7.5Fr. 40cc IAB (W/O Statlock)0684-00-0568-030684-00-0568-032016-09-15
10607567109435Sensation Plus 8Fr. 50cc IAB (W/O Statlock)0684-00-0576-030684-00-0576-032016-09-15
10607567109442Sensation Plus 7.5Fr. 40cc IAB W/ Accessories (W/O Statlock)(China)0684-00-0568-050684-00-0568-052016-09-15
10607567109565Sensation Plus 7.5Fr. 40cc IAB with Accessories, US Only0684-00-0568-01U0684-00-0568-01U2016-09-15
10607567109619MEGA 8Fr. 50cc IAB with Accessories, US Only0684-00-0296-01U0684-00-0296-01U2016-09-16
10607567109626MEGA 8Fr. 50cc IAB with Accessories (APA), US Only0684-00-0296-02U0684-00-0296-02U2016-09-16

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
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
10801902218909ARROWTELEFLEX INCORPORATEDDSP2024-04-29