BioButton Rechargeable Adhesives (ADD-HT) N/A

GUDID 10850005949241

Adhesive accessory packs for wearable devices - 5 pcs, ADD, HT; SKU: ADH-AC1-BBR-5-1-1-10

BIOINTELLISENSE, INC.

Dressing-fixation skin adhesive tape, non-silicone
Primary Device ID10850005949241
NIH Device Record Keycde0eba4-a345-46e8-8da1-9bdd06282fd3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioButton Rechargeable Adhesives (ADD-HT)
Version Model NumberADH-AC1-BBR-5-1-1-10
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
GS100850005949244 [Primary]
GS100850005949435 [Package]
Contains: 00850005949244
Package: Box 12x5 [12 Units]
In Commercial Distribution
GS110850005949241 [Package]
Contains: 00850005949244
Package: Inner Carton - 50x5 [50 Units]
Discontinued: 2022-07-20
Not in Commercial Distribution
GS120850005949248 [Package]
Contains: 00850005949244
Package: Inner Carton - 2x5 [2 Units]
Discontinued: 2022-07-20
Not in Commercial Distribution
GS120850005949439 [Package]
Contains: 00850005949435
Package: Inner Carton 5x12x5 [5 Units]
In Commercial Distribution
GS130850005949245 [Package]
Package: MC-6x50x5 [6 Units]
Discontinued: 2022-07-20
Not in Commercial Distribution
GS130850005949436 [Package]
Contains: 20850005949439
Package: Master Carton 6x5x12 [6 Units]
In Commercial Distribution
GS140850005949242 [Package]
Contains: 20850005949248
Package: MC-100x2x5 [100 Units]
Discontinued: 2022-07-20
Not 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 Date2022-07-28
Device Publish Date2022-07-20

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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