BioButton Rechargeable Adhesives N/A

GUDID 10850005949234

Adhesive accessory packs for wearable devices

BIOINTELLISENSE, INC.

Basic skin adhesive tape
Primary Device ID10850005949234
NIH Device Record Keyf5a74b41-9586-4fae-8eb4-4e75433df6d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioButton Rechargeable Adhesives
Version Model NumberACCS-1-ST06-1-4
Catalog NumberN/A
Company DUNS116984478
Company NameBIOINTELLISENSE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005949237 [Primary]
GS110850005949234 [Package]
Contains: 00850005949237
Package: 50-pack Inner Carton [50 Units]
In Commercial Distribution
GS120850005949231 [Package]
Package: 6-box Master Carton [6 Units]
In Commercial Distribution
GS130850005949238 [Package]
Contains: 00850005949237
Package: 2-pack Inner Carton [2 Units]
In Commercial Distribution
GS140850005949235 [Package]
Contains: 30850005949238
Package: 100-mailer Master Ca [100 Units]
In Commercial Distribution

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-09
Device Publish Date2022-03-01

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

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