Home GUDID 00681490872843 InCheck™ AT PATIENT ASSISTANT
Primary DI 00681490872843
Brand InCheck™ AT PATIENT ASSISTANT
Company MEDTRONIC, INC.
Model 9465
Device description ACCESSORY 9465 ACTIVATOR PAT HND HLD 5L
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
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name LWS Implantable cardioverter defibrillator (non-CRT)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00681490872843 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00681490872843 00681490872843 681490872843 0681490872843
GMDN Terms# Term, Definition table Term Definition Cardiac pulse generator reader, home-use An 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 Type Low High Condition Storage Environment Temperature -40 Degrees Fahrenheit 150 Degrees Fahrenheit
Regulatory Flags# DUNS number 006261481 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 05414734500586 NA ST. JUDE MEDICAL, INC. LWS 2025-05-07 00763000180010 Sprint Quattro Secure S™ MEDTRONIC, INC. LWS 2024-11-04 00763000180058 Sprint Quattro Secure S MRI™ SureScan™ MEDTRONIC, INC. LWS 2024-11-04 00802526623400 NA BOSTON SCIENTIFIC CORPORATION LWS 2024-08-29 05415067049414 Entrant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 05415067049421 Gallant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 05415067049469 Entrant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 05415067049476 Gallant™ ST. JUDE MEDICAL, INC. LWS 2024-04-25 00763000369743 Epsila EV™ MEDTRONIC, INC. LWS 2023-11-03 00763000368470 Aurora EV-ICD™ MRI SureScan™ MEDTRONIC, INC. LWS 2023-11-02 00763000369767 Epsila EV™ MRI SureScan™ MEDTRONIC, INC. LWS 2023-11-02 00763000571528 NA MEDTRONIC, INC. LWS 2023-07-30 05415067037121 Merlin™ ST. JUDE MEDICAL, INC. LWS 2022-08-29 00802526615108 EMBLEM™ S-ICD Programmer BOSTON SCIENTIFIC CORPORATION LWS 2022-01-26 00802526588280 RESONATE™ HF ICD VR BOSTON SCIENTIFIC CORPORATION LWS 2021-07-12 00802526588310 RESONATE™ HF ICD DR BOSTON SCIENTIFIC CORPORATION LWS 2021-07-12 05415067032812 myMerlinPulse™ ST. JUDE MEDICAL, INC. LWS 2021-01-07 00763000178338 Cobalt™ XT DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00763000178345 Cobalt™ XT DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00763000178451 Cobalt™ XT VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00763000178468 Cobalt™ XT VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-11-22 00643169720589 Evera MRI™ S VR SureScan® MEDTRONIC, INC. LWS 2020-11-13 00643169837751 Evera MRI™ XT VR SureScan™ MEDTRONIC, INC. LWS 2020-11-13 00763000060060 Visia AF MRI™ S VR SureScan™ MEDTRONIC, INC. LWS 2020-09-04 05415067031990 Gallant™ ST. JUDE MEDICAL, INC. LWS 2020-09-02 05415067032836 Entrant™ ST. JUDE MEDICAL, INC. LWS 2020-09-02 00763000178390 Cobalt™ DR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00763000178499 Cobalt™ VR MRI SureScan™ MEDTRONIC, INC. LWS 2020-06-08 00802526611322 ZOOM® LATITUDE® BOSTON SCIENTIFIC CORPORATION LWS 2019-11-07 00802526610516 EMBLEM™ S-ICD Programmer BOSTON SCIENTIFIC CORPORATION LWS 2019-11-06
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