Who else makes this device?

Name: Filter,hydophobic, Set,barb 3/PK
Brand: Filter,hydophobic, Set,barb 3/PK

Filter,hydophobic, Set,barb 3/PK · Filter, Bacterial, Breathing-Circuit → Anesthesiology

15manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Filter,hydophobic, Set,barb 3/PK
Listed by	Sunset Healthcare Solutions, Inc., United States
FDA product code	CAH
Device type	Filter, Bacterial, Breathing-Circuit
Device class	Class 2
Regulation	21 CFR 868.5260
Establishment	Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2018-07-31

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Filter,hydophobic, Set,barb 3/PK
Catalogue number	Size	Per pack	Status
SUHBF4053		3	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
K102483	2011-09-13

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.

Filter,hydophobic, Set,barb 3/PK