Who else makes this device?

Name: Vocsn Patient Breathing Package
Brand: Vocsn Patient Breathing Package

Anesthesiology › TherapeuticDevice, Positive Pressure Breathing, Intermittent

Vocsn Patient Breathing Package

VOCSN Patient Breathing Package (Pediatric, Passive, Oxygen, Blue)

Registry build 21.09.26

1manufacturer

7catalogue numbers in this listing

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 Vocsn Patient Breathing Package
Listed by	Ventec Life Systems, Inc., United States
FDA product code	NHJ
Device type	Device, Positive Pressure Breathing, Intermittent
Device class	Class 2
Regulation	21 CFR 868.5905
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K162877
Record published	2017-11-11
Record revised	2025-12-10 (version 7)

Specifications

Specifications
MRI safety	MR Unsafe
Single use	Yes
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date
Packaging	Pack of 10

Catalogue Numbers

Catalogue numbers for Vocsn Patient Breathing Package
Catalogue number	Size	Status
Adult, Passive, Oxygen, Blue		In distribution
Adult, Active, Oxygen, Blue		In distribution
Adult, Active, Oxygen, Blue		In distribution
Pediatric, Active, Oxygen, Blue		In distribution
Pediatric, Passive, Blue		In distribution
Pediatric, Active, Blue		In distribution
Pediatric, Passive, Oxygen, Blue		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
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
Vortran PercussiveNEB 2.0 w/ Top Nebulizer Port	Vortran Medical Technology 1, Inc.	1

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

Recalls Naming This Product

5 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Vocsn Patient Breathing Package
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Ventec Life Systems, Inc.	510(k) number	2026-05-08	Class II	Vendor change control	Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and abs	1
Ventec Life Systems, Inc.	510(k) number	2026-03-25	Class I	Process change control	Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to r	42
Ventec Life Systems, Inc.	510(k) number	2025-02-03	Class I	Component change control	Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less i	30
Ventec Life Systems, Inc.	510(k) number	2024-01-09	Class I	Process control	The bonded spiral wrap may detach before or during ventilation due to a manufacturing issue. Detachment of the spiral wrap can compromise structural integrity, functionality and/ or performance resulting in occlusions or leaks of the breat	250 breathing circuits
Ventec Life Systems, Inc.	510(k) number	2021-05-10	Class II	Device Design	Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.	1,934 devices (415 device that have not been updated)

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.