FDA.reportPublic FDA data

Passy-Muir

Primary DI
10859760005025
Brand
Passy-Muir
Company
PASSY-MUIR, INC.
Model
PMV 007
Catalog number
PMV 007
Device description
Passy-Muir® Tracheostomy & Ventilator Swallowing and Speaking Valve PMV® 007 (Aqua Color™)
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
K903699000
K944451000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903699000PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MMPassy & Passy, Inc.1990-09-04JOH
K944451000PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)Passy-Muir, Inc.1995-07-07JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859760005025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085976000502510859760005025

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.

Contacts#

Phone, Email table
PhoneEmail
9498338255info@passy-muir.com

Regulatory Flags#

DUNS number
174508630
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10859760005056Passy Muir PM-HMEPM-HME2025-02-03
00859760005059Passy Muir PM-HMEPM-HME2025-02-03
10859760005070Passy-Muir PM-DB15PM-DB152022-08-04
30859760005135Passy-MuirPMV-AD22PMV-AD222024-01-09
10859760005094Passy-Muir PM-OCLNPM-OCLN2022-08-04
10859760005124Passy-MuirPMV-AD1522PMV-AD15222020-08-03
10859760005131Passy-MuirPMV-AD22PMV-AD222020-08-03
10859760005001Passy-Muir PM-APF15PM-APF152024-11-18
00859760005073Passy-Muir PM-DB15PM-DB152022-08-04
10859760005018Passy-MuirPMV 005 PMV 0052016-09-16
10859760005032Passy-MuirPMV 2020 PMV 2020 2016-09-16
10859760005063Passy-MuirPMV 2000 PMV 2000 2016-09-16
10859760005087Passy-MuirPMA 2000PMA 20002016-09-16
10859760005148Passy-MuirPMV 2001PMV 20012016-09-16

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Primary DI, Brand, Company table
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