FDA.reportPublic FDA data

Glucology

Primary DI
09352945004355
Brand
Glucology
Company
IBD MEDICAL
Model
Dexcom G6 CGM Patches - Purple
Device description
Adhesive Sensor Patch
Published
2024-02-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
09352945004355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352945004355093529450043559352945004355

GMDN Terms#

Term, Definition table
TermDefinition
Cable/lead/sensor non-conductive skin-adherent patchAn adhesive, non-conductive patch/pad intended to secure a cable/lead/sensor used during a medical procedure [e.g., cardiopulmonary resuscitation (CPR) sensor, ECG lead, phototherapy unit cable] to the skin of a patient. It has no electrical or conducting components or properties and is made of synthetic polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
747092954
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09352945004256GlucologyFreestyle CGM Patches - Beige2024-02-02
09352945004263GlucologyFreestyle CGM Patches - Black2024-02-02
09352945004270GlucologyDexcom G6 CGM Patches - Beige2024-02-02
09352945004287GlucologyDexcom G6 CGM Patches - Black2024-02-02
09352945004294GlucologyMedtronic CGM Patches - Beige 2024-02-02
09352945004317GlucologyMedtronic CGM Patches - Black2024-02-02
09352945004324GlucologyFreestyle CGM Patches - Planets2024-02-02
09352945004331GlucologyFreestyle CGM Patches - Flowers2024-02-02
09352945004348GlucologyFreestyle CGM Patches - Cactus2024-02-02
09352945004362GlucologyDexcom G6 CGM Patches - Blue2024-02-02
09352945004379GlucologyDexcom G6 CGM Patches - Planets2024-02-02
09352945004386GlucologyDexcom G6 CGM Patches - Flowers2024-02-02
09352945004393GlucologyDexcom G6 CGM Patches - Cactus2024-02-02
09352945004409GlucologyLibre Guardian CGM Patches - Planets2024-02-02
09352945004416GlucologyLibre Guardian CGM Patches - Flowers2024-02-02
09352945004423GlucologyLibre Guardian CGM Patches - Cactus2024-02-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998095641Transpore™Solventum US LLCKGX2026-09-25
00197998095672Transpore™Solventum US LLCKGX2026-09-25
00197998095702Transpore™Solventum US LLCKGX2026-09-25
00197998095733Transpore™Solventum US LLCKGX2026-09-25
00197998095788Transpore™Solventum US LLCKGX2026-09-25
00197998103612Transpore™Solventum US LLCKGX2026-09-25
00197998103636Transpore™Solventum US LLCKGX2026-09-25
00197998164118Transpore™Solventum US LLCKGX2026-09-25
06979191883744OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883751OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883768OKTAPEHTT Technologies, Inc.KGX2026-09-02
06979191883775OKTAPEHTT Technologies, Inc.KGX2026-09-02
00850087488785CeeportCEEPORT INC.KGX2026-08-26
00850087488792CeeportCEEPORT INC.KGX2026-08-26
00197998149016Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149047Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149078Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149382Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149412Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149443Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149474Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998149504Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00197998185557Solventum™ Tegaderm™Solventum US LLCKGX2026-08-23
00029369133334McDavidShock Doctor, Inc.KGX2026-08-18
00050428143216CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-08-18
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