FDA.reportPublic FDA data

Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7

Primary DI
10607567114231
Brand
Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7
Company
DATASCOPE CORP.
Model
0884-00-0019-22U
Catalog number
0884-00-0019-22U
Device description
Insertion Kit with 7.5Fr. 6” (15cm) Introducer for Use with the SENSATION PLUS 7.5Fr 40cc IAB
Published
2024-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607567114231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060756711423110607567114231

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator and/or a vascular catheter introduction needle (e.g., arterial needle), and typically an additional access device(s) [e.g., guidewire, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually for arterial access; some sets include in addition noninvasive supportive devices (e.g., drapes, dressings). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
001660786
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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
10607567107479Arrow Pump Adapter - 5 Pack - for use with the Mega 8 Fr. 50cc IAB only0684-00-0510-020684-00-0510-022016-09-23

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Primary DI, Brand, Company table
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20801902219606ARROWTELEFLEX INCORPORATEDDSP2025-04-30
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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