FDA.reportPublic FDA data

ARROW

Primary DI
20801902172079
Brand
ARROW
Company
TELEFLEX INCORPORATED
Model
IPN917286
Catalog number
IAP-0701
Device description
AC3 Series IABP System
Published
2021-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
false

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20801902172079Direct MarkingGS10
10801902172072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080190217207920801902172079
1080190217207210801902172072

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
Special Storage Condition, Specify00Store between -15 Celsius and 40 Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10801902218909ARROWTELEFLEX INCORPORATEDDSP2024-04-29
10801902218916ARROWTELEFLEX INCORPORATEDDSP2024-04-29