BioButton v2 SKU# B2-ST05-02-0-00-GY

GUDID 10850005949142

The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients.

BIOINTELLISENSE, INC.

Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder
Primary Device ID10850005949142
NIH Device Record Key254ef23d-d407-4743-8d35-5462e6693ced
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioButton v2
Version Model NumberBIOST05020F
Catalog NumberSKU# B2-ST05-02-0-00-GY
Company DUNS116984478
Company NameBIOINTELLISENSE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com
Phone+1 888-908-8804
Emailsupport@biointellisense.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005949145 [Primary]
GS110850005949142 [Package]
Contains: 00850005949145
Package: Master Carton [165 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

Devices Manufactured by BIOINTELLISENSE, INC.

10850005949142 - BioButton v22021-05-03The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients.
10850005949142 - BioButton v22021-05-03 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res
10850005949104 - BioButton2021-04-26 The BioButton™ is a remote monitoring wearable device intended to collect physiological data which can include heart rate, res
00850005949008 - BioSticker™2020-05-11 The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home
00850005949046 - BioSticker™ System Offload Software2020-05-11 Offload Software for the BioSticker System.

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