BioSticker™

GUDID 00850005949008

The BioSticker™ System is a wearable remote monitoring system intended for continuous collection of physiological data in home and healthcare settings.

BIOINTELLISENSE, INC.

Electrocardiography telemetric monitoring system transmitter
Primary Device ID00850005949008
NIH Device Record Key32ff8831-9fd3-455c-8409-315a00e78e74
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioSticker™
Version Model NumberBIOST01021F
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-908-8804
Emailsupport@biointellisense.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005949008 [Primary]

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 Date2020-05-11
Device Publish Date2020-05-01

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

Trademark Results [BioSticker]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOSTICKER
BIOSTICKER
90746009 not registered Live/Pending
BioIntelliSense, Inc.
2021-06-01
BIOSTICKER
BIOSTICKER
88719861 not registered Live/Pending
BioIntelliSense, Inc.
2019-12-09

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