Who else makes this device?

Name: CAREvent MRI
Brand: CAREvent MRI

Anesthesiology › TherapeuticVentilator, Emergency, Powered (Resuscitator)

CAREvent MRI

CAREvent MRI is pneumatically powered, time/volume cycled, intermittent positive pressure patient ventilators specifically designed for use by trained personnel in the pre-hospital,…

Registry build 21.09.26

CAREvent MRI is pneumatically powered, time/volume cycled, intermittent positive pressure patient ventilators specifically designed for use by trained personnel in the pre-hospital, hospital, interhospital and air ambulance environments. It has independent controls for minute volume and frequency that provide a comprehensive range of 12 ventilation frequencies and 12 minute-volume settings. This provides a possible 144 combinations of delivered tidal volume and respiratory rate. The various modes of operation of the ventilators support the resuscitation and transportation of a wide range of patients (from infants to adults). The CAREvent MRI contains no ferrous metals and is suitable for use in a three-Tesla MRI environment.

4manufacturers in China registered for this device type

1catalogue number

5510(k) clearances naming this product code

3recalls on this code

Who Else Makes It

Concentrated in Guangdong (3), Fujian (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BTL
Manufacturer	City	Province	Registered as	Device types
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
Sunmed AP, Ltd., Warehouse NO. 2	Zhuhai	Guangdong	Contract manufacturer	16
Dongguan Plastiflex Hose Technology Ltd	Dongguan	Guangdong	Contract manufacturer	3

Record

Regulatory record for CAREvent MRI
Listed by	O-TWO Medical Technologies, Inc., Canada
FDA product code	BTL
Device type	Ventilator, Emergency, Powered (Resuscitator)
Device class	Class 2
Regulation	21 CFR 868.5925
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K051469
Record published	2015-10-23
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	MR Conditional
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -40 to 60 °C
Sizes	Weight 6.25 lb; height 4.3 in; width 6.5 in; length 9.25 in

Catalogue Numbers

Catalogue numbers for CAREvent MRI
Catalogue number	Size	Status
01CV7000	Weight 6.25 lb	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Life Support Products	Allied Medical LLC	50
Neo-Tee T-Piece Resuscitator	Mercury Medical Enterprises, LLC	45
Pneupac	ICU Medical, Inc	38
Allied Medical LLC	Allied Medical LLC	19
Fisher & Paykel Healthcare	Fisher & Paykel Healthcare, Ltd.	18
AincA	Anesthesia Associates, Inc.	17
Neo-Tee T-Piece Resuscitator Circuit	Mercury Medical Enterprises, LLC	12
Life Support Products (LSP)	Allied Medical LLC	12
Moves	Thornhill Research Inc.	11
Ventlab	Ventlab, LLC	7
Resusa-Tee T-Piece Resuscitator	Mercury Medical Enterprises, LLC	7
Curaplex	Bound Tree Medical, LLC	5

Showing 12 of 70. All products under Ventilator, Emergency, Powered (Resuscitator)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K141595	2015-03-16
K093862	2010-05-06
K081330	2009-03-06
K051469	2005-09-28
K051889	2005-08-30

Recalls

3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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
2019-02-12	Class I	Process control	There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa	119	2023-06-29
2019-02-12	Class I	Process control	There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa	136	2023-06-29
2019-02-12	Class I	Process control	There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main boa	632	2023-06-29

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.