FDA.reportPublic FDA data

Vivify Health Care Team Portal 001

Primary DI
00850032055246
Brand
Vivify Health Care Team Portal 001
Company
Vivify Health, Inc.
Model
Vivifyhealth CTP001
Device description
Vivify Remote Patient Monitoring consists of the Care Team Portal, patient portals, and accessory devices.
Published
2024-02-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K222398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222398000Care Team PortalVivify Health, Inc.2023-02-06DRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032055246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032055246008500320552468500320552460850032055246

GMDN Terms#

Term, Definition table
TermDefinition
Multiparameter physiologic analysis workstationA computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
414-238-5673Stefanie_koenig@optum.com
719-238-6258s.iskra@vivifyhealth.com
413-695-1092a.fagade@vivifyhealth.com

Regulatory Flags#

DUNS number
833028959
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850032055253Vivifyhealth SK011SK0112024-06-03
00850032055000Vivifyhealth Kit 006VIV0062024-02-19
00850032055017Vivifyhealth Kit 007VIV0072024-02-19
00850032055024Vivifyhealth Kit 008VIV0082024-02-19
00850032055031Vivifyhealth Kit 001VIV0012024-02-19
00850032055048Vivifyhealth Kit 002VIV0022024-02-19
00850032055055Vivifyhealth Kit 003VIV0032024-02-19
00850032055062Vivifyhealth Kit 004VIV0042024-02-19
00850032055079Vivifyhealth Kit 005VIV0052024-02-19
00850032055086Vivifyhealth Kit 009VIV0092024-02-19
00850032055093Vivifyhealth Kit 010VIV0102024-02-19
00850032055109Vivifyhealth Kit 011VIV0112024-02-19
00850032055116Vivifyhealth Kit 012VIV0122024-02-19
00850032055123Vivifyhealth Kit 013VIV0132024-02-19
00850032055130Vivify Health Kit 014VIV0142024-02-19
00850032055147Vivifyhealth SK001SK0012024-02-19
00850032055154Vivifyhealth SK002SK0022024-02-19
00850032055161Vivifyhealth SK003SK0032024-02-19
00850032055178Vivifyhealth SK004SK0042024-02-19
00850032055185Vivifyhealth SK005SK0052024-02-19

Other Devices Sharing Product Codes#

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