Medline Industries, Inc.
CIRCUIT,ANES,PED,EXP,2BV,1L,LF
15manufacturers in China registered for this device type
405catalogue 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 | Medline Industries, Inc., United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| 510(k) | K033008 |
| Record published | 2016-09-29 |
| Record revised | 2025-11-24 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 40, case of 15, case of 50, case of 10, case of 16 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNJAA10466 | In distribution | |
| DYNJAA6523A | In distribution | |
| DYNJAP6169F | In distribution | |
| DYNJAA10467 | In distribution | |
| DYNJAA10134A | In distribution | |
| DYNJAA10430 | In distribution | |
| DYNJAA10458 | In distribution | |
| 72F1013-1-30 | In distribution | |
| DYNJAA10061 | In distribution | |
| DYNJAA10339 | In distribution | |
| DYNJAA10435 | In distribution | |
| DYNJAA10220 | In distribution | |
| 60F1412-1 | In distribution | |
| DYNJAA10144 | In distribution | |
| DYNJAAF6478A | In distribution | |
| DYNJ54416 | In distribution | |
| DYNJAP6114B | In distribution | |
| DYNJAA10588 | In distribution | |
| DYNJAA10168 | In distribution | |
| DYNJAAF6415C | In distribution | |
| DYNJAA9120 | In distribution | |
| DYNJAP9840 | In distribution | |
| DYNJAA9804B | In distribution | |
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| DYNJAP9906 | In distribution | |
| DYNJAA4836A | In distribution | |
| DYNJAAB0110 | In distribution | |
| DYNJAA6417 | In distribution | |
| DYNJAAB9120 | In distribution | |
| DYNJ1001A | In distribution | |
| DYNJAA10625 | In distribution | |
| DYNJAP0012 | In distribution | |
| DYNJAA10111 | In distribution | |
| DYNJAA10465 | In distribution | |
| DYNJAA10107A | In distribution | |
| DYNJAA6588 | In distribution | |
| DYNJAA4871 | In distribution | |
| DYNJAAF6596 | In distribution | |
| 3000 | In distribution | |
| DYNJAA9844B | In distribution | |
| DYNJAA10468 | In distribution | |
| 02-2001 | In distribution | |
| DYNJAAF6291B | In distribution | |
| DYNJAA9948 | In distribution | |
| DYNJAA10183A | In distribution | |
| DYNJAAF6386C | In distribution | |
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| DYNJAP9836 | In distribution | |
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| DYNJAP9878 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2025-10-10 | Class I | Nonconforming Material/Component | Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120″ expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may resu | 96,406 total units | |
| King Systems Corporation. | 510(k) number | 2017-03-15 | Class II | Nonconforming Material/Component | Potential for leak test failures. | 871,116 units | 2018-12-17 |
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.