FDA.reportPublic FDA data

VORTRAN PercussiveNEB 2.0

Primary DI
10637320080305
Brand
VORTRAN PercussiveNEB 2.0
Company
VORTRAN MEDICAL TECHNOLOGY 1, INC
Model
8030
Catalog number
8030
Device description
The PercussiveNEB 2.0 is an intrapulmonary percussive treatment device that incorporates a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions.
Published
2017-11-02
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
20637320080302PackageGS110In Commercial Distribution
10637320080305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063732008030220637320080302
1063732008030510637320080305

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
916-648-8460vyang@vortran.com

Regulatory Flags#

DUNS number
090508636
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
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
10637320040309VORTRAN PercussiveNEBPNB-4030PNB-40302016-06-14
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

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