Ventlab
MRI Compatible PEEP w/ Transport Circuit & Filter- NS (10/CS)
15manufacturers in China registered for this device type
40catalogue numbers in this listing
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.
| 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
| Listed by | Ventlab, LLC, United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| Record published | 2023-07-17 |
| Record revised | 2025-02-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: General Warehouse. Do not get wet. |
| Packaging | Box of 50, box of 10 |
| Sizes | Outer diameter 15 to 30 mm; lumen/inner diameter 15 to 30 mm; length 9 ft |
| Distribution end date | 2026-01-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FH603027 | Outer Diameter 22 mm | In distribution |
| FH603010 | Outer Diameter 22 mm | In distribution |
| FH603006 | Outer Diameter 22 mm | In distribution |
| PRO-6051 | Outer Diameter 30 mm | In distribution |
| FH603007 | Outer Diameter 22 mm | In distribution |
| FH603003 | Outer Diameter 22 mm | In distribution |
| BE864 | In distribution | |
| FH603013 | Outer Diameter 22 mm | In distribution |
| VC1010 | Length 9 ft | In distribution |
| FH603074 | Outer Diameter 22 mm | In distribution |
| PRO-6054 | Outer Diameter 22 mm | In distribution |
| FH603009 | Outer Diameter 22 mm | In distribution |
| FH603014 | Outer Diameter 22 mm | In distribution |
| FH603008 | Outer Diameter 22 mm | In distribution |
| FH603021 | Outer Diameter 15 mm | In distribution |
| FH603011 | Outer Diameter 22 mm | In distribution |
| N-S705-30 | In distribution | |
| FH603005 | Outer Diameter 15 mm | In distribution |
| N-S705-31 | In distribution | |
| VC1000 | Length 9 ft | In distribution |
| BF102 | Outer Diameter 30 mm | In distribution |
| FH603008FC | Outer Diameter 22 mm | In distribution |
| VC1000F | Length 9 ft | In distribution |
| BF103 | Outer Diameter 30 mm | In distribution |
| FH603023 | Outer Diameter 22 mm | In distribution |
| FH603012 | Outer Diameter 22 mm | In distribution |
| FH603023F | Outer Diameter 15 mm | In distribution |
| FH603026 | Outer Diameter 22 mm | In distribution |
| PRO-6053 | Outer Diameter 22 mm | In distribution |
| FH603003B | Outer Diameter 22 mm | In distribution |
| FH603022 | Outer Diameter 22 mm | In distribution |
| FH603028 | Outer Diameter 22 mm | In distribution |
| FH603020 | Outer Diameter 15 mm | In distribution |
| FH106380 | Outer Diameter 15 mm | Withdrawn |
| FH710023 | Outer Diameter 22 mm | Withdrawn |
| FH603003CFTC | Outer Diameter 22 mm | Withdrawn |
| fh603004 | Outer Diameter 22 mm | Withdrawn |
| FH603003CFT | Outer Diameter 22 mm | Withdrawn |
| BF300-100AEA | Outer Diameter 22 mm | Withdrawn |
| FH603003CFF | Outer Diameter 22 mm | Withdrawn |
Same 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 |
| VBMax | A-M Systems | 39 |
| Vital Signs™ | AirLife Finland Oy | 38 |
| McKesson | Mckesson Medical-Surgical Inc. | 31 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030271 | 2003-07-07 |
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.