BioButton At-Home Kit with Power Adaptor and Adhesives

GUDID 00850005949411

BioButton At-Home Kit with Power Adaptor and Adhesives

BIOINTELLISENSE, INC.

Wearable multiple physiological parameter recorder, reusable
Primary Device ID00850005949411
NIH Device Record Key8b048a69-f36b-453f-818b-4dd1df5593b8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioButton At-Home Kit with Power Adaptor and Adhesives
Version Model NumberKIT-BBR-3763-5
Company DUNS116984478
Company NameBIOINTELLISENSE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005949404 [Primary]
GS100850005949411 [Package]
Contains: 00850005949404
Package: Master Carton (MC) [50 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 Date2023-11-24
Device Publish Date2023-11-16

Devices Manufactured by BIOINTELLISENSE, INC.

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00850005949411 - BioButton At-Home Kit with Power Adaptor and Adhesives 2023-11-24BioButton At-Home Kit with Power Adaptor and Adhesives
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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