FDA.reportPublic FDA data

InCheck™ AT PATIENT ASSISTANT

Primary DI
00721902825569
Brand
InCheck™ AT PATIENT ASSISTANT
Company
MEDTRONIC, INC.
Model
9465AA
Device description
ACTIVATOR 9465AA PATIENT ACTIVATOR US
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902825569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902825569007219028255697219028255690721902825569

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac pulse generator reader, home-useAn external device intended to enable a layperson to noninvasively extract data from an implanted cardiac pulse generator (i.e., therapeutic active cardiac implant) to provide historic and/or current information on device performance, and may in addition be intended to communicate with a diagnostic cardiac implant (e.g., implantable cardiac monitor); it is not intended to program therapeutic implants and is dedicated to cardiac use. It includes a radio-frequency transmitter/receiver and may be intended to operate independently or in conjunction with a personal computer (PC)/tablet using dedicated software. This is a home-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit150 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
006261481
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00824846024767NABB11A61R102026-10-26
00763000923617USB Flash Drive1560-2026-10-25
00643169013995NA207211A2017-02-02
00643169014008NA2072112017-02-02
00643169014039NA206211A2017-02-02
00643169014046NA2062112017-02-02
00643169014053NA205211A2017-02-02
00643169014060NA2052112017-02-02
00643169014077INPUT™ TS091102A2017-02-02
00643169014084INPUT™ TS091101A2017-02-03
00643169014091INPUT™ TS090037A2017-02-02
00643169014107INPUT™ PS0900232017-02-02
00643169014121INPUT™ PS8933112017-02-02
00643169014138INPUT™ PS8833112017-02-03
00643169014145INPUT™ PS8733112017-02-03
00643169014152INPUT™ PS8633112017-02-02
00643169014169INPUT™ PS8533112017-02-02
00643169014176NA6933112016-08-20
00643169014213NA6633112017-02-02
00643169014220NA6533112017-02-02

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04035479182847Acticor Sky VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183011Rivacor Aura VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183059Rivacor Rise VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
04035479183066Rivacor Rise VR-TBIOTRONIK SE & Co. KGLWS2026-04-20
04035479185695Rivacor Aura VR-T DXBIOTRONIK SE & Co. KGLWS2026-04-20
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05415067050106Entrant™ST. JUDE MEDICAL, INC.LWS2025-02-11
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05415067034809Merlin@home™ST. JUDE MEDICAL, INC.LWS2024-11-13
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