FDA.reportPublic FDA data

Marpac Inc

Primary DI
10653658009511
Brand
Marpac Inc
Company
Marpac, Inc.
Model
951D
Catalog number
951D
Device description
Chin Strap, CPAP, Nicu, LARGE, bag contains 10ea
Published
2023-04-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
10653658009511PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1065365800951110653658009511

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP chin strap, single-useA 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) 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/infant to adult patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-505-344-4740sales@marpacmedical.com

Regulatory Flags#

DUNS number
794035683
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
00653658004007Marpac Inc4002023-04-03
00858388004017BreatheWear Halo Chinstrap by Marpac8-H34078-H34072023-06-06
10653658009504Marpac Inc950D950D2023-04-13
10653658030812Marpac Inc308-1D308-1D2023-04-12
10653658030829Marpac Inc308-2D308-2D2023-04-12
10653658030836Marpac Inc308-3D308-3D2023-04-12
20653658003868Marpac Inc386B386B2023-04-12
20653658003899Marpac Inc389B389B2023-04-12
00653658003017Marpac Inc3012023-04-06
00653658003048Marpac Inc3042023-04-06
00653658003062Marpac Inc3062023-04-06
00653658003208Marpac Inc3202023-04-06
00653658003215Marpac Inc3212023-04-06
00653658003406Marpac Inc3402023-04-06
00653658001051Marpac Inc1052023-04-03
00653658001075Marpac Inc1072023-04-03
00653658001082Marpac Inc1082023-04-03
00653658002010Marpac Inc2012023-04-03
00653658002034Marpac Inc2032023-04-03
00653658002041Marpac Inc2042023-04-03

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
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
10848530088740HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098247CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30