FDA.reportPublic FDA data

VORTRAN PercussiveNEB

Primary DI
10637320040309
Brand
VORTRAN PercussiveNEB
Company
VORTRAN MEDICAL TECHNOLOGY 1, INC
Model
PNB-4030
Catalog number
PNB-4030
Device description
The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home
Published
2016-06-14
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
NHJDevice, Positive Pressure Breathing, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003684000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003684000PERCUSSIVENEB, MODEL PN-2001Vortran Medical Technology 1, Inc.2001-02-23NHJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20637320040306PackageGS110In Commercial Distribution
10637320040309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063732004030620637320040306
1063732004030910637320040309

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic nebulizing systemAn assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.

Contacts#

Phone, Email table
PhoneEmail
916-648-8460lweddington@vortran.com

Regulatory Flags#

DUNS number
090508636
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00637320061239VORTRAN GO2VENT® with Peep Valve612361232025-02-20
10637320062004VORTRAN GO2VENT with PEEP Valve620062002021-05-04
20637320062001VORTRAN GO2VENT with PEEP Valve620062002021-05-04
10637320039600VORTRAN® APM-Plus396039602020-01-30
10637320039006VORTRAN Airway Pressure MonitorAPM-3900APM-39002016-06-14
10637320060017VORTRAN GO2VENT600160012019-05-03
10637320000112VORTRAN GO2VENT 660066002019-04-19
20637320050503VAR Surgical Center KitPCK-5050PCK-50502016-07-14
20637320060014VORTRAN GO2VENT600160012019-05-03
10637320000105VORTRAN GO2VENT612361232017-06-07
10637320000167VORTRAN GO2VENT6123-166123-162017-06-07
10637320024507VCI (VORTRAN Cuff Inflator)245024502018-08-31
10637320040200VORTRAN-IPPBIP-4020IP-40202016-06-14
10637320040217VORTRAN-IPPB with Water TrapIPW-4021IPW-40212016-06-14
10637320040224VORTRAN-IPPB with ManomterIPM-4022IPM-40222016-06-14
10637320050001VAR (VORTRAN Automatic Resuscitator)PT-5000PT-50002015-11-04
10637320050018VAR (VORTRAN Automatic Resuscitator) with ManometerPTM-5001PTM-50012015-11-04
10637320050025VAR (VORTRAN Automatic Resuscitator) with ExtensionPTE-5002PTE-50022015-11-04
10637320050100VAR (VORTRAN Automatic Resuscitator)PC-5010PC-50102015-11-05
10637320050117VAR (VORTRAN Automatic Resuscitator) with ManometerPCM-5011PCM-50112016-06-14

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