FDA.reportPublic FDA data

JBC

Primary DI
04719871892237
Brand
JBC
Company
FOREMOUNT ENTERPRISE CO., LTD.
Model
450-3023
Device description
Mask Harness, Silicone
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
04719871892237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871892237047198718922374719871892237

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia mask strap, single-useA non-sterile, non-latex strap/head harness intended to hold an anaesthesia mask in position on a patient's face. It is typically wrapped around the patient's head and affixed to the mask. It is typically used for anaesthesia of long duration. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658718465
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871896730Aero US1FAXX-00772026-02-12
04719871896747Aero US1FAXX-01012026-02-12
04719871896754Aero US1FAXX-01182026-02-12
04719871896761Aero US1FCXX-00242026-02-12
04719871896778Aero US1FCXX-00262026-02-12
04719871896785Aero US1FDXX-00312026-02-12
04719871896792Aero US1FM4A-00252026-02-12
04719871896808Aero US1FM4A-00352026-02-12
04719871897874KEMP USA10-5012026-02-12
04719871897881KEMP USA10-501-SE2026-02-12
04719871897898KEMP USA10-5252026-02-12
04719871897904KEMP USA10-525-NL2026-02-12
04719871897911KEMP USA10-5262026-02-12
04719871897928KEMP USA10-5142026-02-12
04719871897935Code One1FAXX-00162026-02-12
04719871897942Code One1FAXX-01092026-02-12
04719871892251JBC400-1046/252024-07-18
04719871890011WNLME6201B-FAK5000GIRED2024-06-28
04719871890028WNLME6201NB2-FAK5000SGI2024-06-28
04719871890042WNLME6201NB12-FAK5000SG2024-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00848530080396HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30