BioButton Adhesive V2 (ADH-CS) N/A

GUDID 00850005949534

BioButton Cold Seal Adhesive V2 (ADH-CS)

BIOINTELLISENSE, INC.

Dressing-fixation skin adhesive tape, non-silicone
Primary Device ID00850005949534
NIH Device Record Key10538fee-8fe6-458e-9ac7-6119479517d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioButton Adhesive V2 (ADH-CS)
Version Model NumberADH-CS-10771
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005949510 [Package]
Contains: 00850005949541
Package: ADH-CS-60-10813 [60 Units]
In Commercial Distribution
GS100850005949527 [Package]
Contains: 00850005949541
Package: ADH-CS-7-11264 [7 Units]
In Commercial Distribution
GS100850005949534 [Package]
Contains: 00850005949541
Package: ADH-CS-30-10813 [30 Units]
In Commercial Distribution
GS100850005949541 [Primary]
GS110850005949517 [Package]
Contains: 00850005949510
Package: ADH-CS-60B-10813 [5 Units]
In Commercial Distribution
GS110850005949524 [Package]
Contains: 00850005949527
Package: ADH-CS-7M-11264 [100 Units]
In Commercial Distribution
GS120850005949514 [Package]
Contains: 10850005949517
Package: ADH-CS-60M-10813 [6 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 Date2024-05-09
Device Publish Date2024-05-01

Devices Manufactured by BIOINTELLISENSE, INC.

00850005949534 - BioButton Adhesive V2 (ADH-CS)2024-05-09BioButton Cold Seal Adhesive V2 (ADH-CS)
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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