FDA.reportPublic FDA data

CPAPology

Primary DI
00663427001083
Brand
CPAPology
Company
Kego Corporation
Model
CY-K8540
Catalog number
CY-K8540
Device description
CPAPology Halo Chinstrap
Published
2023-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BTKStrap, Head, Gas Mask

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00663427001083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00663427001083006634270010836634270010830663427001083

GMDN Terms#

Term, Definition table
TermDefinition
Pressure bandage, non-latex, single-useA strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
208120423
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00663427000482KINGKM-S022KM-S0222023-11-09
00663427000543KINGKM-S023KM-S0232023-11-09
00663427000574KINGKM-S025KM-S0252023-11-09
00663427000581KINGKM-S026KM-S0262023-11-09
00663427000499KINGKM-S020KM-S0202023-11-07
00663427000505KINGKM-S021KM-S0212023-11-07
00663427000529KINGKM-S011KM-S0112023-11-07
00663427000536KINGKM-S008KM-S0082023-11-07
00663427001113KINGKM-1320/EKM-13202023-11-07
00663427000598KING Shielded Acq. CableKM-P050580RG 2021-12-08
00663427000604KING Shielded Acq. CableKM-P050580R 2021-12-08
00663427000123KING Connector KM-PA0302RBG2019-06-04
00663427000130KING Electrode Lead CableKM-PA01005B2019-06-04
00663427000147KING Electrode Lead CableKM-PA01005G2019-06-04
00663427000154KING Electrode Lead CableKM-PA01005R2019-06-04
00663427000161KING Electrode Lead CableKM-PA01036G2019-06-04
00663427000178KING Electrode Lead CableKM-PA01048B2019-06-04
00663427000185KING Electrode Lead CableKM-PA01048G2019-06-04
00663427000192KING Electrode Lead CableKM-PA01048R2019-06-04
00663427000208KING Electrode Lead CableKM-PA01060B2019-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530109691CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2026-09-09
00848530109080CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2026-06-04
00848530109103CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2026-06-04
10889483002742Mask HarnessSUNMED, LLCBTK2026-03-19
00848530085902CPAP HeadgearSunset Healthcare Solutions, Inc.BTK2025-11-12
06922166514068HeadgearSuzhou Yuyue Medical Technology Co., Ltd.BTK2025-10-10
06922166513894HeadgearSuzhou Yuyue Medical Technology Co., Ltd.BTK2025-09-30
06978333140011OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140028OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140004OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06978333140035OTIXiamen Oti Electronic Industry Co., Ltd.BTK2025-04-11
06946430423313CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
06946430423320CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423310CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423327CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
10889483606827AirLife™AIRLIFEBTK2025-03-03
10889483606841AirLife™AIRLIFEBTK2025-03-03
10889483606858AirLife™AIRLIFEBTK2025-03-03
10889483606865AirLife™AIRLIFEBTK2025-03-03
10889483606872AirLife™AIRLIFEBTK2025-03-03
10889483606896AirLife™AIRLIFEBTK2025-03-03
10889483606919AirLife™AIRLIFEBTK2025-03-03
30889483606821AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606845AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606852AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606869AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606876AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606890AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
30889483606913AirLife™Sunmed Group Holdings, LLCBTK2025-03-03
00848530088743HeadgearSunset Healthcare Solutions, Inc.BTK2024-07-30