Filter, Bacterial, Breathing-Circuit

Who Makes This Device Type in China?

10 of the 15 manufacturers in China registered for this device type are contract manufacturers, able to build to a buyer’s own specification. They are concentrated in Jiangsu, Guangdong and Zhejiang, and 2 other provinces.

Amsino Medical (Shanghai) Co., Ltd. Shanghai, contract manufacturer
Changshu Rozer Sterilization Technology Co., Ltd. Jiangsu, contract manufacturer
Conod Medical Co., Limited Jiangsu, contract manufacturer
Flexicare Medical (Dongguan) Ltd. Guangdong, contract manufacturer
GVS Technology (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
GaleMed (Xiamen) Co., Ltd. Fujian, contract manufacturer
Intersurgical Medical Apparatus (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
Ningbo Huakun Medical Equipment Co., Ltd. Zhejiang, contract manufacturer
Rozer Sterilization Technology Shuyang Company Limited Jiangsu, contract manufacturer
Shaoxing Haitech Medical Products Co., Ltd. Zhejiang
Sunmed AP, Ltd. Guangdong, contract manufacturer
Sunmed AP, Ltd., Warehouse NO. 2 Guangdong, contract manufacturer
Vincent Medical (Dong Guan) Manufacturing Co., Ltd. Guangdong, contract manufacturer
VR Medical Technology Co., Ltd. Jiangsu, contract manufacturer
Zhejiang Haisheng Medical Device Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code CAH?

Filter, Bacterial, Breathing-Circuit is FDA product code CAH, Class 2, 21 CFR 868.5260.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 4 clearances under this code; the FDA took a median of 299 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 28 recalls under this product code since 2005. None was by a company in China. 12 are Class I, the most serious grade.

The root causes the FDA records most often are Process control (6), Material/Component Contamination (4) and Nonconforming Material/Component (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Filter, Bacterial, Breathing-Circuit

Filter CareStar 30

Catalogue number MP01770, listed by Drägerwerk AG & Co. KGaA, Germany, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

ThermoShield Hmef Luer Port S/Bore Cath Mount D/Swivel Elbow

Catalogue number 038-41-355/325STRU, listed by Flexicare Medical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Hmef W/ Flextube

Catalogue number 19-HMEF100, listed by Geri-Gentle Corporation, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

VBMax30, PF Testing Filter

VBMax30, Pulmonary Function Testing Filter, Labeled DR Burton

Filter, Bacterial, Breathing-Circuit

6IN HEPA Capsule With Removable Sticker

6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum 5 and 10 TM, and PerfectO2TM

Filter, Bacterial, Breathing-Circuit

Disposable Anesthesia Breathing Circuits

108" Pediatric Expandable Circuit

Filter, Bacterial, Breathing-Circuit

9064/M/712BRSA059/0001

62.002.0118.9064/M/712BRSA

Filter, Bacterial, Breathing-Circuit

PFT Kit E, VBMax36E W/ Foam Nose Clip

Pulmonary Function Testing Kit E, VBMax36E w/ Foam Nose Clip

Filter, Bacterial, Breathing-Circuit

Baterial/Viral Filter Mini

Catalogue number 038-42-360U, listed by Flexicare Medical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

72` 28v Adult HW Circuit, PAR WYE

72` 28V Adult HW Circuit,PAR WYE,Water,BV Filter,Water Trap

Filter, Bacterial, Breathing-Circuit

Servo Duo Guard 1pcs

Catalogue number 6884725, listed by Maquet Critical Care AB, Sweden, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

72′ Adult Uni-Lim™ Coaxial Circuit

*72`Adult Uni-Lim™, plain elbow, HEPA w/port, 2L LF Bag 900 Large

Filter, Bacterial, Breathing-Circuit

VBMax30L

VBMax30L, Disposable Pulmonary Function Testing Filter GraceMed

Filter, Bacterial, Breathing-Circuit

HEPA Filter

Catalogue number 4244-701 BRSA, listed by GVS Technology (Suzhou) Co., Ltd., China, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Bact-HME Basic

Catalogue number 6000, listed by Pharma Systems Ps AB, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

VBMax34S, PF Testing Filter Labeled DR Burton

VBMax34S, Pulmonary Function Testing Filter Labeled DR Burton

Filter, Bacterial, Breathing-Circuit

High Deadspace Body

Catalogue number 3888/01BIUA019/0001, listed by GVS Filter Technology UK Ltd, United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT Kit F, VBMax36S

Catalogue number PFT Kit F, VBMax36S - 187156, listed by A-M Systems, United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

96″ Adult Expandable Anesthesia Circuit

96" Adult Expandable Anesthesia Circuit, Parallel Wye, w/GSP, GSE, 2L not made with latex breathing bag, B/V Filter, 900 Series large mask

Filter, Bacterial, Breathing-Circuit

Angled HME With Luer Lock Port

Catalogue number FL-70115, listed by Besmed Health Business Corporation, Taiwan, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

CombiStar Plus Filter + HME Flex

Catalogue number MP12061, listed by Drägerwerk AG & Co. KGaA, Germany, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

6126a

Catalogue number 6126A, listed by Arc Medical, Inc., United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

EverFlo Kit

(1) BF1001, (1) BF316NS, (1) OF1006NS

Filter, Bacterial, Breathing-Circuit

9080/M/710BRSA

62.002.0109.9080/M/710BRSA

Filter, Bacterial, Breathing-Circuit

Filter SafeStar 60a

Catalogue number MP01795, listed by Drägerwerk AG & Co. KGaA, Germany, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT Kit, Disposable, AstraGuard / Noseclip

Catalogue number PFT Kit, Disposable, AstraGuard and Nose, listed by A-M Systems, United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

VBMax35s, PF Testing Filter Labeled DR Burton

VBMax35s, Pulmonary Function Testing Filter Labeled DR Burton

Filter, Bacterial, Breathing-Circuit

Pulmonary Function Test Kit B, VBMax 48 MM

Pulmonary Function Test Kit B, Disposable, VBMax 48 MM, with Blue Foam Nose Clip

Filter, Bacterial, Breathing-Circuit

Nebulizer Compressor Filter

Catalogue number 6313, listed by Westmed, Inc., United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Hmef W/Luer Lock Port (Dead Space 60ml)

Catalogue number FL-70303, listed by Besmed Health Business Corporation, Taiwan, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Clear-Therm 3 Hmef L/Port Retainable CAP

Catalogue number 1541000, listed by Intersurgical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Aero-Sat

Catalogue number 102302, listed by Pulmodyne Inc., United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT Kit G, VBMax28E

Pulmonary Function Testing Kit G, VBMax28E

Filter, Bacterial, Breathing-Circuit

PFT Kit E, VBMax28E, W/ Foam Nose Clip

Pulmonary Function Testing Kit E, VBMax28E, w/ Foam Nose Clip

Filter, Bacterial, Breathing-Circuit

Filter CareStar 20 Plus

Catalogue number MP05770, listed by Drägerwerk AG & Co. KGaA, Germany, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

4333/M/712BRSA059/0001

62.002.0112.4333/M/712BRSA

Filter, Bacterial, Breathing-Circuit

Bact-Trap Midi Port

Catalogue number 7110, listed by Pharma Systems Ps AB, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT Kit E, 36mm E-Series Kit

Pulmonary Function Test Kit E, 36mm e-Series Kit

Filter, Bacterial, Breathing-Circuit

VBMax30E

VBMax30E, Disposable Pulmonary Function Testing Filter

Filter, Bacterial, Breathing-Circuit

Uni-Lim 60″ Adult Coaxail Breathing Circuit

Uni-Lim 60" Adult Coaxail Breathing Circuit, 24" Flex Expiratory, Clear GSE, GSL 10' x .060" ID M/M, ISL 10" x .060" ID Female, 3L not made with latex breathing bag, B/V Filter, Inline HMEF…

Filter, Bacterial, Breathing-Circuit

Inter-Therm Hmef With Superset™ Catheter Mount – Sterile

Catalogue number 1341011S, listed by Intersurgical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Kit, ViroMax, 24″ Tubing, for Cosmed Bod Pod

Catalogue number Kit, ViroMax, 24" Tubing - 180013, listed by A-M Systems, United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Aero-Sat Filter Small Angled

Catalogue number 102402, listed by Pulmodyne Inc., United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT KIT A, 36 MM O.D.

Pulmonary Function Testing KIT A, 36 MM O.D.

Filter, Bacterial, Breathing-Circuit

CLEAR-GUARD3 Angled Breathing Filter With Luer Port AND 22F/15M-22M/15F

Catalogue number 1545000, listed by Intersurgical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT Kit F, VBMax34S, W/ Foam Nose Clip

Pulmonary Function Testing Kit F, VBMax34S, w/ Foam Nose Clip

Filter, Bacterial, Breathing-Circuit

96″ Adult Expandable Circuit, Swivel Wye, Large Mask

96"Adult Expandable Circuit, swivel Wye, GSE, 2 BV, 3LF, 10' GSL, Large Mask

Filter, Bacterial, Breathing-Circuit

PFT Kit B, 33 MM O.D. W/ White Foam Nose Clip

Pulmonary Function Testing Kit B, Disposable, Qty 100, 33 MM O.D. W/ White Foam Nose Clip

Filter, Bacterial, Breathing-Circuit

ThermoShield Paediatric Bacterial Viral Hmef With Luer Port

Catalogue number 038-42-355STRU, listed by Flexicare Medical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT Kit G, VBMax36E

Pulmonary Function Testing Kit G, VBMax36E

Filter, Bacterial, Breathing-Circuit

Servo Guard 1pcs

Catalogue number 6884724, listed by Maquet Critical Care AB, Sweden, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Inter-Therm Hmef – Sterile

Catalogue number 1341007S, listed by Intersurgical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

VBMax34E, Disposable PF Testing Filter

VBMax34E, Disposable Pulmonary Function Testing Filter - VectraCor

Filter, Bacterial, Breathing-Circuit

Ulti-MistHME/F

HME/F Ulti-Mist

Filter, Bacterial, Breathing-Circuit

LuerSafe Mini Bacterial Viral Filter With Self-Sealing Luer Port

Catalogue number 038-42-365LSU, listed by Flexicare Medical Ltd., United Kingdom, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Adult, Dual Limb Circuit

Circuit, Disposable, 22mm, Non-Heated, Dual Limb, Bacterial Viral Filter

Filter, Bacterial, Breathing-Circuit

HME W/Luer Lock Port (Dead Space 45ml)

Catalogue number FL-70112, listed by Besmed Health Business Corporation, Taiwan, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

72`adult Uni-Lim™, GSE 2 BV Filter 3l

72`Adult Uni-Lim™, GSE 2 BV Filter 3L, LF Bag 900 Yankauer NV, NS

Filter, Bacterial, Breathing-Circuit

Pall Conserve™ Small Volume HME

Conserve Small Volume HME with Monitoring Port. For use with mechanically ventilated patients to retain heat and humidity while removing bacterial/viral contaminants with an efficiency of…

Filter, Bacterial, Breathing-Circuit

Hmef W/Luer Lock Port (Dead Space 45ml)

The FDA comparison identifies a Besmed HMEF with Luer Lock Port as a subject-device product name. The HME filter absorbs heat and moisture from exhaled gas and releases retained heat and…

Filter, Bacterial, Breathing-Circuit

Aero-Pro

Catalogue number 201012, listed by Pulmodyne Inc., United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

72″adult Circuit, Bi-Wye

72"Adult Circuit, Bi-Wye, plain elbow, tube hanger

Filter, Bacterial, Breathing-Circuit

PFT Kit F, VBMax36E, W/foam Nose Clip

Catalogue number PFT Kit F, VBMax36E, w/foam - 189147, listed by A-M Systems, United States, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

Filter/HME TwinStar 60a Plus

Catalogue number MP05810, listed by Drägerwerk AG & Co. KGaA, Germany, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Filter, Bacterial, Breathing-Circuit

PFT KIT F, Disposable, VBMax34E

Disposable Pulmonary Function Testing KIT F, VBMax34E

Filter, Bacterial, Breathing-Circuit

Filter/HME TwinStar 10a

Catalogue number MP01825, listed by Drägerwerk AG & Co. KGaA, Germany, under Filter, Bacterial, Breathing-Circuit. 15 manufacturers in China are registered for this product code.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer