FDA.reportPublic FDA data

TrachVox

Primary DI
00841470101091
Brand
TrachVox
Company
PULMODYNE INC
Model
313-1000
Published
2016-03-11
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
K013728000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013728000TRACH VOXEngineered Medical Systems2002-07-30JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470101098PackageGS150In Commercial Distribution
00841470101091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010109810841470101098
00841470101091008414701010918414701010910841470101091

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an ""artificial nose"", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device."

Contacts#

Phone, Email table
PhoneEmail
337-246-5500info@pulmodyne.com

Regulatory Flags#

DUNS number
030619483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470100841Percussor313-41962026-05-29
00841470100858Percussor313-41972026-05-29
00841470104740BiTrac Select313-95892025-09-30
00841470104764BiTrac Select313-95912025-09-30
00841470100148O2-MAX313-8201-62025-04-12
00841470105501BiTrac101615782025-04-11
00841470105518BiTrac 101615772025-04-11
00841470105525BiTrac101615792025-04-11
00841470105532BiTrac101615762025-04-11
00841470105549BiTrac 101600492025-04-11
00841470105556BiTrac 101600502025-04-11
00841470105563BiTrac 101600512025-04-11
00841470105570BiTrac 101600522025-04-11
00841470105587BiTrac SE101600532025-04-11
00841470105594BiTrac SE101600542025-04-11
00841470105600BiTrac SE101600552025-04-11
00841470105617BiTrac SE101600562025-04-11
00841470105631BiTrac Select101617662025-04-11
00841470105648BiTrac Select101617672025-04-11
00841470105655BiTrac Select101617682025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709200668BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200675BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200682BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200699BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200705BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200729BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200736BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200767BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200781BivonaICU MEDICAL, INC.JOH2026-08-07
10887709198385BivonaICU MEDICAL, INC.JOH2026-08-03
10887709198866BivonaICU MEDICAL, INC.JOH2026-08-03
10887709198880BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199368BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199580BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199641BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199764BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199771BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199788BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199801BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199818BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199825BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199832BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199849BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199856BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199863BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200002BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200019BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200026BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200033BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200149BivonaICU MEDICAL, INC.JOH2026-08-03