FDA.reportPublic FDA data

PACEART® SYSTEM GET CONNECTED III

Primary DI
00613994533241
Brand
PACEART® SYSTEM GET CONNECTED III
Company
MEDTRONIC, INC.
Model
PASTMGCIII
Device description
SW PASTMGCIII PACEART GLBL MR GCIII
Published
2016-04-01
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
DPSELECTROCARDIOGRAPH
DXHTRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE
KREANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DXHTransmitters And Receivers, Electrocardiograph, TelephoneCardiovascular2
KREAnalyzer, Pacemaker Generator Function, IndirectCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K024278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K024278000PACEART SYSTEMMedtronic Vascular2003-05-29DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994533241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994533241006139945332416139945332410613994533241

GMDN Terms#

Term, Definition table
TermDefinition
Patient health record information system application softwareAn application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150083855NABB10L80R82026-06-08
00199150083992NABB8B99R92026-06-08
00199150084180NA1D92R42026-06-08
00824846000020NABB12W54R22026-06-08
00824846000983NABB12W65R2026-06-08
00824846001027NABB12C06R52026-06-08
00824846001041NABB12W64R2026-06-08
00824846001065NABB12V57R2026-06-08
00643169530102ATTAIN CLARITY™62252016-07-16
00613994746610ATTAIN SELECT™ II6248130D022016-07-16
00613994746801ATTAIN SELECT™ II6248DEL90DS022016-04-11
20763000946979DLP®872202024-08-15
00199150078455NA11N40R12026-04-26
20643169454594DLP®303172016-09-09
00199150083077NA12V42R2026-05-30
00199150083121NABB1119R72026-05-30
00199150083381NABB12M28R122026-05-30
00199150083442NABB5G97R132026-05-30
00199150083534NABB10U10R172026-05-30
00199150083718NABB6Z03R102026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732094354959Welch Allyn, Inc.WELCH ALLYN, INC.DPS2026-06-09
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DXH2026-06-03
00850086928008SENSINEL™ CPM BASE STATIONAnalog Devices, Inc.DPS2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DXH2026-06-03
00850086928015SENSINEL™ CPM WEARABLEAnalog Devices, Inc.DPS2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928022SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DXH2026-06-03
00850086928039SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM)Analog Devices, Inc.DPS2026-06-03
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B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
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B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DPS2026-05-27