Who else makes this device?

Name: Vivo 65
Brand: Vivo 65

Vivo 65 · Ventilator, Continuous, Facility Use → Anesthesiology

8manufacturers in China registered for this device type

6catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CBK
Manufacturer	City	Province	Registered as	Device types
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Mehow Innovative (Huizhou) Ltd.	Huizhou	Guangdong	Contract manufacturer	11
Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	8
Beijing Aeonmed Co., Ltd.	Sanhe	Hebei	Contract manufacturer	7
Shenzhen Mindray BIO-Medical Electronics Co., Ltd.	Shenzhen	Guangdong	Specification developer	61
GE Medical Systems (China) Co., Ltd.	Wuxi	Jiangsu	Contract manufacturer	57

Record

Regulatory record for Vivo 65
Listed by	Breas Medical, Inc., United States
FDA product code	CBK
Device type	Ventilator, Continuous, Facility Use
Device class	Class 2
Regulation	21 CFR 868.5895
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K160481
Record published	2022-06-18

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date
Packaging	Box of 10

Catalogue Numbers

Catalogue numbers for Vivo 65
Catalogue number	Per pack	Status
005521		In distribution
005523		In distribution
006435	5	In distribution
006342		In distribution
005525		In distribution
005432		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Puritan Bennett	Covidien LP	285
Newport	Newport Medical Instruments, Inc.	103
LTV	Vyaire Medical, Inc.	92
Ventilator, Continuous, Facility Use	Hans Rudolph, Inc.	66
Infant Flow SiPAP	Carefusion	62
Avea	Carefusion	57
Ventoux	Flight Medical Innovations Ltd.	48
Trilogy	Respironics Inc.	42
Avea™	Vyaire Medical, Inc.	39
Patient Circuits	Zoll Medical Corporation	38
Performatrak	Respironics Inc.	35
Bio-Med Devices, Inc.	BIO-MED Devices, Inc.	34

Showing 12 of 419. All products under Ventilator, Continuous, Facility Use

Recalls Naming This Product

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

Recalls naming the identifiers of Vivo 65
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Breas Medical, Inc.	510(k) number	2020-01-28	Class II	Device Design	The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover.	629	2020-09-15
Breas Medical, Inc.	510(k) number	2018-05-08	Class III	Employee error	Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool.	45	2020-05-04

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2022-03-21	Class II	Process control	Ventilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the imme	707 units	2024-12-13

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.

Vivo 65