FDA.reportPublic FDA data

AirLife™

Primary DI
10889483606919
Brand
AirLife™
Company
AIRLIFE
Model
TMS-13
Catalog number
TMS-13
Published
2025-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
30889483606913PackageGS11In Commercial Distribution
10889483606919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360691330889483606913
1088948360691910889483606919

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP chin strap, reusableA non-latex device in the form of a strap or band intended to be fastened around a patient’s head (vertically from chin to crown) during continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) therapy using a nasal mask or cannula, to control mouth air leaks by gently holding the mouth closed. It is available in sizes appropriate for neonatal to adult patients. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
119058668
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190752146662Vital Signs™5612VS5612VS2019-12-20
10889483586761Vital Signs™5612VS5612VS2025-02-12
10889483589175BROSELOW™7730FLY7730FLY2025-03-07
10889483589182BROSELOW™7730FLYY7730FLYY2025-03-13
10889483598276BROSELOW™BPOC01ABPOC01A2025-03-13
10190752144743AirLife™4S78XX004S78XX002020-01-15
10190752152946AirLife™10855-85510855-8552021-05-07
10889438651308AirlifeCK-25-0026CK-25-00262026-04-15
10889483570906AirLife™0020030020032025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief Valve0020060020062025-02-20
10889483570999AirLife™0021730021732025-02-20
10889483572283AirLife™1006-H051006-H052025-02-17
10889483572528AirLife™10155N-50410155N-5042025-02-12
10889483572559AirLife™10225-50410225-5042025-02-12
10889483572658AirLife™10303N-50410303N-5042025-03-05
10889483572672AirLife™10333-50410333-5042025-02-17
10889483572818AirLife™10604-85510604-8552025-02-12
10889483572825AirLife™10608-70110608-7012025-02-12
10889483572870AirLife™10746-85510746-8552025-02-12
10889483572900AirLife™10794-H1210794-H122025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10848530088740HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098247CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098254CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30