FDA.reportPublic FDA data

BioButton Adhesive V2 (ADH-CS)

Primary DI
00850005949541
Brand
BioButton Adhesive V2 (ADH-CS)
Company
BIOINTELLISENSE, INC.
Model
ADH-CS-10771
Catalog number
N/A
Device description
BioButton Cold Seal Adhesive V2 (ADH-CS)
Published
2024-05-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGXTape And Bandage, Adhesive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850005949510PackageGS160In Commercial Distribution
00850005949527PackageGS17In Commercial Distribution
00850005949534PackageGS130In Commercial Distribution
10850005949517PackageGS15In Commercial Distribution
10850005949524PackageGS1100In Commercial Distribution
20850005949514PackageGS16In Commercial Distribution
00850005949541PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850005949510008500059495108500059495100850005949510
00850005949527008500059495278500059495270850005949527
00850005949534008500059495348500059495340850005949534
1085000594951710850005949517
1085000594952410850005949524
2085000594951420850005949514
00850005949541008500059495418500059495410850005949541

GMDN Terms#

Term, Definition table
TermDefinition
Dressing-fixation skin adhesive tape, non-siliconeA long and narrow flexible band of non-silicone-based material (e.g., fabric, plastic, paper) coated on one or both sides with a pressure-sensitive adhesive, intended to non-invasively adhere to the skin surface to fix a dressing in place or attach objects (e.g., catheter, lamp); it might have hypoallergenic and/or waterproof properties. This is a single-use device.

Regulatory Flags#

DUNS number
116984478
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005949466BioDashboardSW-BDBN/A2025-02-28
00850005949671BioButton Charging StationCRG-BBM-18299N/A2025-11-19
00850005949558BioButton (Reprocessed)BBR-B-I-Rn/a2025-02-19
00850005949565BioButton (Reprocessed, NF Version)BBR-B-I-R (BBR-B-NF-I-R)n/a2025-02-19
00850005949596BioButton Charging StationCRG-12685N/A2025-02-19
10850005949555BioButton (Reprocessed)BBR-B-I-Rn/a2025-02-19
10850005949562BioButton (Reprocessed, NF Version)BBR-B-I-R (BBR-B-NF-I-R)n/a2025-02-19
10850005949593BioButton Charging StationCRG-12685N/A2025-02-19
00850005949442BioButton Rechargeable Device, Multi-PatientBBRM-B-I-NN/A2025-02-11
10850005949449BioButton Rechargeable Device, Multi-PatientBBRM-B-I-NN/A2025-02-11
00850005949534BioButton Adhesive V2 (ADH-CS)ADH-CS-10771N/A2024-05-01
00850005949244BioButton Rechargeable Adhesives (ADD-HT)ADH-AC1-BBR-5-1-1-10N/A2022-07-20
00850005949299BioButton v3 (BBN-r, different batch)BIOST060402023-09-05
00850005949282BioButton (In Bulk Packaging)BIOST0604F v2.12023-07-03
00850005949312BioButton At-Home Kit with Power AdaptorKIT-BBR-3763-12023-11-16
00850005949343BioButton At-Home Kit with Power Adaptor, Adhesives and BioButtonKIT-BBR-3763-32023-11-16
00850005949367BioButton At-Home Kit with Adhesives and BioButtonKIT-BBR-3763-42023-11-16
00850005949381BioButton At-Home KitKIT-BBR-3763-22023-11-16
00850005949404BioButton At-Home Kit with Power Adaptor and Adhesives KIT-BBR-3763-52023-11-16
00850005949336BioButton At-Home Kit with Power AdaptorKIT-BBR-3763-12023-11-16

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08859922800050EquateWAL-MART STORES, INC.KGX2026-09-30
08859922800067EquateWAL-MART STORES, INC.KGX2026-09-30
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