FDA.report

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
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JAYSupport, Breathing Tube

Product Code Classifications

CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00653658009019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00653658009019006536580090196536580090190653658009019

GMDN Terms

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

Contacts

PhoneEmail
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
10653658022053Marpac Inc220SD220SD2023-04-10
00653658003017Marpac Inc3012023-04-06
00653658003024Marpac Inc3022023-04-06
00653658003048Marpac Inc3042023-04-06
00653658003055Marpac Inc3052023-04-06
00653658003062Marpac Inc3062023-04-06
00653658003208Marpac Inc3202023-04-06
00653658003215Marpac Inc3212023-04-06
00653658003406Marpac Inc3402023-04-06
00653658001020Marpac Inc1022023-04-03
00653658001051Marpac Inc1052023-04-03
00653658001068Marpac Inc1062023-04-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20889483228576Capette™SUNMED, LLCJAY2025-12-31
20889483225469Septal-H™SUNMED, LLCJAY2025-12-16
10889483225431Septal-H™SUNMED, LLCJAY2025-12-15
10889483225448Septal-H™SUNMED, LLCJAY2025-12-15
10889483225455Septal-H™SUNMED, LLCJAY2025-12-15
10889483226506AirLife™SUNMED, LLCJAY2025-12-15
10889483226513AirLife™SUNMED, LLCJAY2025-12-15
10889483228586Capette™SUNMED, LLCJAY2025-12-15
10889483228593Capette™SUNMED, LLCJAY2025-12-15
10889483228609Strapette™SUNMED, LLCJAY2025-12-15
10889483228616Strapette™SUNMED, LLCJAY2025-12-15
10889483228623Capette™SUNMED, LLCJAY2025-12-15
10889483228630Capette™SUNMED, LLCJAY2025-12-15
10889483228647Capette™SUNMED, LLCJAY2025-12-15
10889483228654Strapette™SUNMED, LLCJAY2025-12-15
10889483228661Strapette™SUNMED, LLCJAY2025-12-15
10889483228692SavEar™ SUNMED, LLCJAY2025-12-15
10889483230244AirLife™SUNMED, LLCJAY2025-12-15
00850014574604PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
00860013561406MPVMovair, Inc.JAY2025-03-12
00860013561413MPVMovair, Inc.JAY2025-03-12
00860010190845AcanthusAcanthus Medical Creations LLCJAY2024-12-13
00860010190852AcanthusAcanthus Medical Creations LLCJAY2024-12-13
04250105611465Anesthetic Tube Holder with 3-Joint-SystemVBM Medizintechnik GmbHJAY2024-06-25
04250105611472Pressure Transducer HolderVBM Medizintechnik GmbHJAY2024-06-25
04250105611489Anesthetic Tube Holder with 3-Joint-SystemVBM Medizintechnik GmbHJAY2024-06-25
04250105611427Anesthetic Tube Holder with 3-Joint-SystemVBM Medizintechnik GmbHJAY2024-06-20
10080196150090MedlineMEDLINE INDUSTRIES, INC.JAY2024-03-27
10850014574809Endo TiePEPPER MEDICAL INC.JAY2023-10-25
00850014574611Trach TiePEPPER MEDICAL INC.JAY2023-10-25