FDA.reportPublic FDA data

Montgomery® Tracheostomy Speaking Valve

Primary DI
14063107100014
Brand
Montgomery® Tracheostomy Speaking Valve
Company
Boston Medical Products, Inc.
Model
221202
Catalog number
221202
Device description
Size: 15 mm; Color: White
Published
2022-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOHTube Tracheostomy And Tube Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K955516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K955516000MONTGOMERY TRACHEOSTOMY SPEAKING VALVEBoston Medical Products, Inc.1995-12-22JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34063107100018PackageGS11In Commercial Distribution
14063107100014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3406310710001834063107100018
1406310710001414063107100014

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube speech valveA device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

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

Contacts#

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

Regulatory Flags#

DUNS number
131855157
Device count
1
Kit
true
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
14063107102902Montgomery® Safe-T-Tube™ Plug/Ring Set3611163611162024-09-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709195131BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195148BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195155BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195162BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195179BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195186BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195193BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195209BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195216BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195223BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195230BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195247BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195254BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195261BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195278BivonaICU MEDICAL, INC.JOH2026-06-08
10887709194967BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194974BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194981BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194998BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195001BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195018BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195025BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195032BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195049BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195056BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195063BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195070BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195087BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195094BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195100BivonaICU MEDICAL, INC.JOH2026-06-05