FDA.reportPublic FDA data

BioButton Rechargeable Adhesives

Primary DI
10850005949234
Brand
BioButton Rechargeable Adhesives
Company
BIOINTELLISENSE, INC.
Model
ACCS-1-ST06-1-4
Catalog number
N/A
Device description
Adhesive accessory packs for wearable devices
Published
2022-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
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
10850005949234PackageGS150In Commercial Distribution
20850005949231PackageGS16In Commercial Distribution
30850005949238PackageGS12In Commercial Distribution
40850005949235PackageGS1100In Commercial Distribution
00850005949237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000594923410850005949234
2085000594923120850005949231
3085000594923830850005949238
4085000594923540850005949235
00850005949237008500059492378500059492370850005949237

GMDN Terms#

Term, Definition table
TermDefinition
Basic skin adhesive tapeA long and narrow flexible band of fabric, plastic, paper, or other material, 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 is not hypoallergenic or waterproof. 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
false
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
00850005949671BioButton Charging StationCRG-BBM-18299N/A2025-11-19
00850005949466BioDashboardSW-BDBN/A2025-02-28
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08809302586487Soosung Self-Adhesive Bandagesoosung medicalKGX2026-06-08
00814247021304Panniculus Retraction KitCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021311Panniculus Retraction Kit: traxi and ABBy - SmallCLINICAL INNOVATIONS, LLCKGX2026-05-31
00814247021328Panniculus Retraction Kit: traxi and ABBy - LargeCLINICAL INNOVATIONS, LLCKGX2026-05-31
00850087488389CeeportCEEPORT INC.KGX2026-05-29
00850087488426CeeportCEEPORT INC.KGX2026-05-29
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
00819143026446HealquHealqu LLCKGX2026-03-05
10192253049817TelfaCardinal Health 200, LLCKGX2026-02-25
10192253050080TelfaCardinal Health 200, LLCKGX2026-02-25
10080196669523MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669530MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10080196669547MEDLINEMEDLINE INDUSTRIES, INC.KGX2026-01-30
10618125192318AquaGuardTIDI PRODUCTS, LLCKGX2025-09-23
10198459392078MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-07-07
10080196691708CURADMEDLINE INDUSTRIES, INC.KGX2025-05-23
10198459343506MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGX2025-05-22
10192253050172TelfaCardinal Health 200, LLCKGX2025-04-18
10192253050189TelfaCardinal Health 200, LLCKGX2025-04-18
10385081120333Omnipod PodPalsInsulet CorporationKGX2025-04-16
10653160999003Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.KGX2025-04-07