FDA.reportPublic FDA data

Glucology

Primary DI
09352945004324
Brand
Glucology
Company
IBD MEDICAL
Model
Freestyle CGM Patches - Planets
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
09352945004324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09352945004324093529450043249352945004324

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
09352945004331GlucologyFreestyle CGM Patches - Flowers2024-02-02
09352945004348GlucologyFreestyle CGM Patches - Cactus2024-02-02
09352945004355GlucologyDexcom G6 CGM Patches - Purple2024-02-02
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
00050428142516CVSWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDKGX2026-05-28
09420012436047Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
09420012436061Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDKGX2026-04-14
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
10197106767726CARDINAL HEALTHCardinal Health 200, LLCKGX2024-10-31
10080196669417MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196669493MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
10080196743032MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-07-31
09355751001259Seer HomeSEER MEDICAL HOLDINGS LIMITEDKGX2024-06-27
10197344102716MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102723MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102730MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102747MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102754MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102761MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102778MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10197344102785MEDLINEMEDLINE INDUSTRIES, INC.KGX2024-06-20
10192253046779KendallCardinal Health 200, LLCKGX2024-06-11