Who else makes this device?

Name: PFT Kit E, VBMax35E w/ Foam Nose Clip
Brand: PFT Kit E, VBMax35E w/ Foam Nose Clip

PFT Kit E, VBMax35E W/ Foam Nose Clip · Filter, Bacterial, Breathing-Circuit → Anesthesiology

15manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Jiangsu (6), Guangdong (4), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAH
Manufacturer	City	Province	Registered as	Device types
Conod Medical Co., Limited	Changshu	Jiangsu	Contract manufacturer	48
Flexicare Medical (Dongguan) Ltd.	Dongguan	Guangdong	Contract manufacturer	48
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29
Amsino Medical (Shanghai) Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	22
Zhejiang Haisheng Medical Device Co., Ltd.	Shaoxing	Zhejiang	Contract manufacturer	21
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
Sunmed AP, Ltd., Warehouse NO. 2	Zhuhai	Guangdong	Contract manufacturer	16
Intersurgical Medical Apparatus (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	12
GVS Technology (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	5
Changshu Rozer Sterilization Technology Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	43
Rozer Sterilization Technology Shuyang Company Limited	Shuyang	Jiangsu	Contract manufacturer	33

Showing 12 of 15. All 15 manufacturers in China registered for Filter, Bacterial, Breathing-Circuit

Record

Regulatory record for PFT Kit E, VBMax35E w/ Foam Nose Clip
Listed by	A-M Systems, United States
FDA product code	CAH
Device type	Filter, Bacterial, Breathing-Circuit
Device class	Class 2
Regulation	21 CFR 868.5260
Establishment	Repacker / relabeller, Manufacturer
510(k)	K000654
Record published	2019-03-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, manufacturing date
Packaging	Pack of 100

Catalogue Numbers

Catalogue numbers for PFT Kit E, VBMax35E w/ Foam Nose Clip
Catalogue number	Size	Status
PFT Kit E, VBMax35E – 189137		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	405
Pulmoguard	S D I Diagnostics Inc	203
Cardinal Health	Cardinal Health 200, LLC	131
DAR	Covidien LP	110
Portex	ICU Medical, Inc	108
Vital Signs™	SunMed Group Holdings, LLC	78
Pentair	Pentair Filtration Solutions	68
Disposable Anesthesia Circuits	Westmed, Inc.	68
AirLife™	AirLife Finland Oy	43
Ventlab	Ventlab, LLC	40
VBMax	A-M Systems	39
Vital Signs™	AirLife Finland Oy	38

Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K130664	2013-06-21
K063526	2007-06-29
K000654	2000-11-14

Recalls

The FDA has not published a severity grade for these. 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
2010-03-31	Not classified	Nonconforming Material/Component	Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.	37800	2012-01-05

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.

PFT Kit E, VBMax35E W/ Foam Nose Clip