FDA.report

Vivify Health Kit 014

Primary DI
00850032055130
Brand
Vivify Health Kit 014
Company
Vivify Health, Inc.
Model
VIV014
Device description
Repackaged Kit 014 which includes Tablet, APK, Sim Card, Scale, Pulse Oximeter, BP Monitor, BP Cuff, Pedometer, Tablet Power Adapter, Tablet Stand, USB Cable, Alkaline Battery
Published
2024-02-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Product Code Classifications

CodeDeviceSpecialtyClass
DRGTransmitters And Receivers, Physiological Signal, RadiofrequencyCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850032055130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032055130008500320551308500320551300850032055130

GMDN Terms

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

Contacts

PhoneEmail
414-238-5673Stefanie_Koenig@vivifyhealth.com

Regulatory Flags

DUNS number
833028959
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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
00850032055147Vivifyhealth SK001SK0012024-02-19
00850032055154Vivifyhealth SK002SK0022024-02-19
00850032055161Vivifyhealth SK003SK0032024-02-19
00850032055178Vivifyhealth SK004SK0042024-02-19
00850032055185Vivifyhealth SK005SK0052024-02-19
00850032055192Vivifyhealth SK006SK0062024-02-19

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