FDA.reportPublic FDA data

Linkview

Primary DI
00763000001964
Brand
Linkview
Company
Medtronic Care Management Services, LLC
Model
100011-032
Device description
HUB TC210 LINKVIEW
Published
2017-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRGTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122285000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122285000TABLET COMMANDERCardiocom, LLC2012-08-14DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000001964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000001964007630000019647630000019640763000001964

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analysis system, home-useA mains electricity (AC-powered) device assembly, sometimes with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)] for intermittent spot-check measuring in the home. It typically includes a main analysis unit with a visual display, and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter) or external devices (e.g., USB cable). It may be used in a healthcare facility or in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
061079989
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000286972Commander Flex™101001-0012019-07-08
00763000286989Commander Flex™101001-0022019-07-08
00763000286996Commander Flex™101001-0032019-07-08
00763000001957Commander Flex™100011-0312017-06-23
00643169838338Commander100016-001A2016-09-10
00643169838345Commander100016-0032016-09-05
00643169838352Commander100016-005A2016-09-09
00643169838369Commander100011-001A2016-09-05
00643169838376Commander100011-002A2016-09-05
00643169838383Commander Flex®100011-0132016-09-08
00643169838390Commander Flex®100011-0152016-09-08
00643169838406Commander Flex®100011-0172016-09-08
00643169838413Commander Flex®100011-0162016-09-08
00643169838420Commander Flex®100011-0202016-09-08
00643169838437Commander Flex®100011-0262016-09-08
00643169838444Commander Flex®100011-0302016-09-08
00643169838451Linkview®100011-0222016-09-08
00643169838468NA100027-001A2016-09-05
00643169838482NA450001-0142016-09-08
00643169838499NA450001-0202016-09-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DRG2026-06-02
04719875011016EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011023EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
04719875011030EZYPRO ECG RecorderSIGKNOW BIOMEDICAL CO., LTD.DRG2026-06-01
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DRG2026-05-27
00195278990914Portrait CSSXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953024096Portrait CVAXBGe Medical Systems Information Technologies, Inc.DRG2025-12-10
00198953030981PORTRAIT HSWXBGE Healthcare Finland OyDRG2025-12-10
B353UB12511UbiqVue HolterLifesignals, Inc.DRG2025-04-22
B353UB22511UbiqVue HolterLifesignals, Inc.DRG2025-04-22