DAR
Adult-Pediatric Electrostatic Filter HME with Connector Small, Tethered Cap
15manufacturers in China registered for this device type
110catalogue numbers in this listing
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 | Covidien LP, United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2026-04-08 (version 14) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Fragile, Keep dry, This side up |
| Packaging | Case of 25, case of 10, case of 50, case of 12, case |
| Distribution end date | 2026-05-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 352U5996 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5805TC | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5836 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5867TC | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5836 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5822 | Tidal Volume, 300-1500, ML; | In distribution |
| 351U5979 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5877TC | Tidal Volume, 150-1200, ML; | In distribution |
| 351/5984 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5867TC | Tidal Volume, 150-1200, ML; | In distribution |
| 5094000 | In distribution | |
| 351/5946 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5877 | Tidal Volume, 150-1200, ML; | In distribution |
| 350/5865 | Tidal Volume,300-1500, ML; | In distribution |
| 5093900 | In distribution | |
| R012 | Female,33/31,N/A; | In distribution |
| 351/5994 | Tidal Volume, 150-1200, ML; | In distribution |
| 4-076408-00 | In distribution | |
| 5093600 | In distribution | |
| R002 | Female,33/25,N/A; | In distribution |
| 352U5805 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5830 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5815 | Tidal Volume, 300-1500, ML; | In distribution |
| 351U5856 | Tidal Volume, 300-1500, ML; | In distribution |
| R024 | Female, 33/Male, 29.5; | In distribution |
| 351P5980 | Tidal Volume, 150-1200, ML; | In distribution |
| 5093500 | In distribution | |
| 351S19044 | Tidal Volume, 150-1200, ML; | In distribution |
| 351U5878 | Tidal Volume, 200-1500, ML; | In distribution |
| 351/5410Z | Tidal Volume, 300-1500, ML; | In distribution |
| 351/5979 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5844 | Tidal Volume, 150-1200, ML; | In distribution |
| 352U5877 | Tidal Volume, 150-1200, ML; | In distribution |
| 350U5865 | Tidal Volume, 300-1500, ML; | In distribution |
| 351/5987 | Tidal Volume, 150-1200, ML; | In distribution |
| 4-076900-00 | In distribution | |
| 350/5865 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5802 | Tidal Volume, 300-1500, ML; | In distribution |
| R003 | Female,33/26,N/A; | In distribution |
| 352/5805 | Tidal Volume, 300-1500, ML; | In distribution |
| 351/5856 | Tidal Volume, 300-1500, ML; | In distribution |
| 355U5427 | Tidal Volume, 30-100, ML; | In distribution |
| 352U5805 | Tidal Volume, 300-1500, ML; | In distribution |
| R016 | Female,33/35,N/A; | In distribution |
| 352/5802 | Tidal Volume, 300-1500, ML; | In distribution |
| 350U5879 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5877TC | Tidal Volume, 150-1200, ML; | In distribution |
| 355U5430 | Tidal Volume, 75-300, ML; | In distribution |
| 351U5410 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5869 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5805TC | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5867 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5866 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5867TC | Tidal Volume, 150-1200, ML; | In distribution |
| 351S19044TC | Tidal Volume, 150-1200, ML; | In distribution |
| R013 | Female,33/32,N/A; | In distribution |
| 352/5901 | Tidal Volume, 150-1200, ML; | In distribution |
| R025 | Female, 33/Male, 30; | In distribution |
| 352/5855 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5881 | Tidal Volume, 150-1200, ML; | In distribution |
| R001 | Female,33/22,N/A; | In distribution |
| 350S19006 | Tidal Volume, 150-1200, ML; | In distribution |
| 350/5879 | Tidal Volume, 150-1200, ML; | In distribution |
| 5093500 | In distribution | |
| 351S19032 | Tidal Volume, 150-1200, ML; | In distribution |
| 351/5410 | Tidal Volume, 300-1500, ML; | In distribution |
| 5093900 | In distribution | |
| 352/5811 | Tidal Volume, 300-1500, ML; | In distribution |
| 500U30022 | In distribution | |
| 352/5864 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5893 | Tidal Volume, 150-1200, ML; | In distribution |
| 355U5430 | Tidal Volume, 75-300, ML; | In distribution |
| 352/5429 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5877TC | Tidal Volume, 150-1200, ML; | In distribution |
| 351/5980 | Tidal Volume, 150-1200, ML; | In distribution |
| 351U5856 | Tidal Volume, 300-1500, ML; | In distribution |
| 5093600 | In distribution | |
| 351/19002 | Tidal Volume, 150-1200, ML; | In distribution |
| 350/5865Z | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5863 | Tidal Volume, 150-1200, ML; | In distribution |
| 352/5864 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5811 | Tidal Volume, 300-1500, ML; | In distribution |
| R015 | Female,33/34,N/A; | In distribution |
| 351S19044TC | Tidal Volume,150-1200,Milliliter; | In distribution |
| 5094000 | In distribution | |
| 350/5879 | Tidal Volume,150-1200, ML; | In distribution |
| 351/5835 | Tidal Volume, 300-1500, ML; | In distribution |
| 352/5877 | Tidal Volume,150-1200, ML; | In distribution |
| 352/5805 | Tidal Volume, 300-1500, ML; | In distribution |
| R023 | Female, 33/Male, 28; | Withdrawn |
| R007 | Female,33/28.5,N/A; | Withdrawn |
| R004 | Female,33/27,N/A; | Withdrawn |
| R026 | Female, 33/Male, 30.5; | Withdrawn |
| R006 | Female,33/28,N/A; | Withdrawn |
| R028 | Female, 33/Male, 32; | Withdrawn |
| R027 | Female, 33/Male, 31; | Withdrawn |
| R010 | Female,33/30,N/A; | Withdrawn |
| R029 | Female, 33/Male, 33.5; | Withdrawn |
| R018 | Female,33/44,N/A; | Withdrawn |
| 350U19006 | Tidal Volume, 150-1200, ML; | Withdrawn |
| R020 | Female, 33/Male, 22; | Withdrawn |
| R005 | Female,33/27.5,N/A; | Withdrawn |
| R017 | Female,33/40,N/A; | Withdrawn |
| R021 | Female, 33/Male, 24; | Withdrawn |
| R014 | Female,33/33,N/A; | Withdrawn |
| R008 | Female,33/29,N/A; | Withdrawn |
| R009 | Female, 33/29/Male, 33; | Withdrawn |
| R011 | Female,33/30.5,N/A; | Withdrawn |
| R019 | Female,33/45,N/A; | Withdrawn |
| R022 | Female, 33/Male, 27; | 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 |
| 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 |
| McKesson | Mckesson Medical-Surgical Inc. | 31 |
Showing 12 of 545. All products under Filter, Bacterial, Breathing-Circuit
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Covidien | UDI-DI | 2021-04-29 | Class II | Material/Component Contamination | The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization. | 32625 |
| Covidien | UDI-DI | 2021-04-29 | Class II | Material/Component Contamination | The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization. | 7200 |
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.