FDA.reportPublic FDA data

Montgomery® Safe-T-Tube™ Plug/Ring Set

Primary DI
14063107102902
Brand
Montgomery® Safe-T-Tube™ Plug/Ring Set
Company
Boston Medical Products, Inc.
Model
361116
Catalog number
361116
Device description
Tracheal T-Tube, 11/12 mm
Published
2024-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K843936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K843936000MONTGOMERY SAFE-T-TUBEBoston Medical Products, Inc.1984-12-14BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14063107102902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1406310710290214063107102902

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube decannulation capA device designed to facilitate tracheostomy tube weaning and removal (decannulation), as well as voice restoration, for patients who have been chronic users of a tracheostomy tube. It is a small plastic cover (a cap), typically brightly coloured for easy identification, that is placed on the proximal end of a fenestrated or uncuffed tracheostomy tube to close the tracheostomy termination. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags#

DUNS number
131855157
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14063107102865Montgomery® Safe-T-Tube™ Plug/Ring Set3610863610862024-09-28
14063107102872Montgomery® Safe-T-Tube™ 15 mm Adaptor3610873610872024-09-28
14063107102889Montgomery® Safe-T-Tube™ Plug/Ring Set3611063611062024-09-28
14063107102896Montgomery® Safe-T-Tube™ 15 mm Adaptor3611073611072024-09-28
14063107102919Montgomery® Safe-T-Tube™ 15 mm Adaptor3611173611172024-09-28
14063107102926Montgomery® Safe-T-Tube™ Plug/Ring Set3611263611262024-09-28
14063107102933Montgomery® Safe-T-Tube™ 15 mm Adaptor3611273611272024-09-28
14063107102940Montgomery® Safe-T-Tube™ Plug/Ring Set3611463611462024-09-28
14063107102957Montgomery® Safe-T-Tube™ 15 mm Adaptor3611473611472024-09-28
14063107103060Montgomery® Safe-T-Tube™4600084600082024-09-28
14063107103077Montgomery® Safe-T-Tube™460008R460008R2024-09-28
14063107103084Montgomery® Safe-T-Tube™4600094600092024-09-28
14063107103091Montgomery® Safe-T-Tube™460009R460009R2024-09-28
14063107103107Montgomery® Safe-T-Tube™4600104600102024-09-28
14063107103114Montgomery® Safe-T-Tube™460010R460010R2024-09-28
14063107103121Montgomery® Safe-T-Tube™4600114600112024-09-28
14063107103138Montgomery® Safe-T-Tube™460011R460011R2024-09-28
14063107103145Montgomery® Safe-T-Tube™4600124600122024-09-28
14063107103152Montgomery® Safe-T-Tube™460012R460012R2024-09-28
14063107103169Montgomery® Safe-T-Tube™4600134600132024-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759399SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759405SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759412SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759429SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759436SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
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14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759511SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759566SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759573SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759740SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750846KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08