FDA.reportPublic FDA data

Marpac Inc

Primary DI
00653658009019
Brand
Marpac Inc
Company
Marpac, Inc.
Model
901-SSDD/107
Catalog number
901D
Device description
Marpac's Stronghold anti-disconnect device for Adult Shiley Flexible and Legacy tracheostomy tubes
Published
2025-06-06
Public version status
New
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
JAYSupport, Breathing Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653658009019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653658009019006536580090196536580090190653658009019

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube neck holder, single-useA non-sterile, noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
794035683
Device count
1
Premarket exempt
true
Lot or batch
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
10653658009511Marpac Inc951D951D2023-04-13
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

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