Who else makes this device?

Name: Vortran PercussiveNEB 2.0
Brand: Vortran PercussiveNEB 2.0

Anesthesiology › TherapeuticDevice, Positive Pressure Breathing, Intermittent

Vortran PercussiveNEB 2.0

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…

Registry build 21.09.26

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.

1manufacturer

1catalogue number

3510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NHJ
Manufacturer	City	Province	Registered as	Device types
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29

Record

Regulatory record for Vortran PercussiveNEB 2.0
Listed by	Vortran Medical Technology 1, Inc., United States
FDA product code	NHJ
Device type	Device, Positive Pressure Breathing, Intermittent
Device class	Class 2
Regulation	21 CFR 868.5905
Establishment	Repacker / relabeller, Manufacturer
510(k)	K003684
Record published	2017-11-02
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for Vortran PercussiveNEB 2.0
Catalogue number	Size	Status
8030		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
CoughAssist	Respironics Inc.	44
Percussionaire	Percussionaire Corp.	40
The MetaNeb®System	Hill-Rom Services Pte, Ltd.	14
The VitalCough®System	Hill-Rom Services Pte, Ltd.	10
Synclara Cough System	Hill-Rom Services Pte, Ltd.	10
Volara System	Hill-Rom Services Pte, Ltd.	9
Vocsn Patient Breathing Package	Ventec Life Systems, Inc.	7
Clearo	Breas Medical, Inc.	6
Maximus System	Hill-Rom Services Pte, Ltd.	6
BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small	Abmrc LLC	3
BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large	Abmrc LLC	3
The Vest APX System	Hill-Rom Services Pte, Ltd.	2

Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K003684	2001-02-23
K982016	1998-11-03
K981726	1998-09-17

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.