FDA.reportPublic FDA data

BioButton Adhesive V2 (ADH-CS)

Primary DI
00850005949534
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
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116984478
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850005949541BioButton 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
069740214114323H MedicalWAL-MART STORES, INC.KGX2026-07-31
069740214114943H MedicalWAL-MART STORES, INC.KGX2026-07-31
06979191882112NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882228NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882242NanacareWAL-MART STORES, INC.KGX2026-07-31
06979191882273BadBuddyWAL-MART STORES, INC.KGX2026-07-31
06979191883591OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883607OKTAPEHTT Technologies, Inc.KGX2026-07-31
06979191883690EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883706EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883713EQUATEWAL-MART STORES, INC.KGX2026-07-31
06979191883720EquateWAL-MART STORES, INC.KGX2026-07-31
06980297490019HuixiangJiangsu Huixiang Intelligent Technology Co., LtdKGX2026-07-31
20618125192339AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192384AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
20618125192391AquaGuardTIDI PRODUCTS, LLCKGX2026-07-28
00850086064003BRIJ-SEALBRIJ Medical, Inc.KGX2026-07-17
B14350202030IDcheck SensorBeacon Biosignals, Inc.KGX2026-07-17
00850088144598CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-10
00850088144093CARBOUNingbo kehu Medical Technology Co.,Ltd.KGX2026-07-01
14931921902902BLUPRO Attachment TapeNIHON KOHDEN CORPORATIONKGX2026-06-23
00850087488556CeeportCEEPORT INC.KGX2026-06-12
16973405130119AODEJIANWenzhou Anqi Medical Supplies Co., LtdKGX2026-06-10
00049696189583THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696561228THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00049696677547THERA PlusFOURSTAR GROUP INC.KGX2026-06-09
00197344129099CURADMEDLINE INDUSTRIES, INC.KGX2026-06-09
08809302586364Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586395Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
08809302586425Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08