BioButton (In Bulk Packaging) P/N: BBR-B-B-N

GUDID 00850005949282

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, reusable
Primary Device ID00850005949282
NIH Device Record Key419f665c-daf6-49bd-914c-389ef6f085a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioButton (In Bulk Packaging)
Version Model NumberBIOST0604F v2.1
Catalog NumberP/N: BBR-B-B-N
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
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
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
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
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 25 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005949282 [Primary]
GS110850005949289 [Package]
Package: Bulk Packaging [195 Units]
Discontinued: 2023-07-03
Not in Commercial Distribution
GS120850005949286 [Package]
Package: Inner Carton [12 Units]
In Commercial Distribution
GS130850005949283 [Package]
Contains: 20850005949286
Package: Master Carton (MC) [16 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 Date2023-07-11
Device Publish Date2023-07-03

Devices Manufactured by BIOINTELLISENSE, INC.

00850005949534 - BioButton Adhesive V2 (ADH-CS)2024-05-09 BioButton Cold Seal Adhesive V2 (ADH-CS)
00850005949336 - BioButton At-Home Kit with Power Adaptor2023-11-24 BioButton At-Home Kit with Power Adaptor
00850005949350 - BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton2023-11-24 BioButton At-Home Kit with Power Adaptor, Adhesives and BioButton
00850005949374 - BioButton At-Home Kit with Adhesives and BioButton2023-11-24 BioButton At-Home Kit with Adhesives and BioButton
00850005949398 - BioButton At-Home Kit2023-11-24 BioButton At-Home Kit
00850005949411 - BioButton At-Home Kit with Power Adaptor and Adhesives 2023-11-24 BioButton At-Home Kit with Power Adaptor and Adhesives
10850005949227 - BioButton v3 (BBN-r, different batch, Individual Pack)2023-10-06 Note: 00850005949220 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from d
00850005949299 - BioButton v3 (BBN-r, different batch)2023-09-13 Note: 00850005949299 (Model# BIOST06040) is equivalent to BBN-r (BBN v3) (01) 00850005949183 (Model# BIOST06040F), coming from d

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