FDA.report

Marpac Inc

Primary DI
10653658009504
Brand
Marpac Inc
Company
Marpac, Inc.
Model
950D
Catalog number
950D
Device description
Chin Strap, CPAP, Nicu, SMALL, bag contains 10ea
Published
2023-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BTKStrap, Head, Gas Mask

Product Code Classifications

CodeDeviceSpecialtyClass
BTKStrap, Head, Gas MaskAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10653658009504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1065365800950410653658009504

GMDN Terms

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

Contacts

PhoneEmail
1-505-344-4740sales@marpacmedical.com

Regulatory Flags

DUNS number
794035683
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00653658001051Marpac Inc1052023-04-03
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16946430423310CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
16946430423327CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDBTK2025-03-18
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
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10848530088740HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098247CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
00848530098254CPAP MasksSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-30
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00848530091507HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-23
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00848530091491HeadgearSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-15
00848530040468CPAP FilterSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-09
00848530080112Chin StrapSUNSET HEALTHCARE SOLUTIONS, INC.BTK2024-07-09
04719871892237JBCFOREMOUNT ENTERPRISE CO., LTD.BTK2024-06-28
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