Vital Signs™
Vital Signs™ Anesthesia Circuit Kit, 72" Flexible Dual-Limb, Patient Elbow with Sampling Port, Parallel Wye, In-Line Mini HMEF with Sample Port, Large Adult Mask, M/M GSL 10' X .050ID X…
Vital Signs™ Anesthesia Circuit Kit, 72″ Flexible Dual-Limb, Patient Elbow with Sampling Port, Parallel Wye, In-Line Mini HMEF with Sample Port, Large Adult Mask, M/M GSL 10′ X.050ID X.108OD, 3 L Latex-Free Breathing Bag, Disposable
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 | SunMed Group Holdings, LLC, United States |
|---|---|
| FDA product code | CAH |
| Device type | Filter, Bacterial, Breathing-Circuit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5260 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2025-12-22 |
| Record revised | 2026-04-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature -20 to 50 °C |
| Packaging | Box of 20, box of 10, box of 15, box, box of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9391 | In distribution | |
| 9809 | In distribution | |
| 9566 | In distribution | |
| 9361 | In distribution | |
| 8244 | In distribution | |
| 9623 | In distribution | |
| 9392 | In distribution | |
| 6888 | In distribution | |
| 9565 | In distribution | |
| 9177 | In distribution | |
| 9335 | In distribution | |
| 9153A | In distribution | |
| 9362 | In distribution | |
| 9677 | In distribution | |
| 9432 | In distribution | |
| 9804 | In distribution | |
| 9810 | In distribution | |
| 9811 | In distribution | |
| 9802 | In distribution | |
| 9663 | In distribution | |
| 9129 | In distribution | |
| 9303 | In distribution | |
| 8569 | In distribution | |
| 9806 | In distribution | |
| 9344 | In distribution | |
| 6887 | In distribution | |
| 9357 | In distribution | |
| 9363 | In distribution | |
| 7-SP5659 | In distribution | |
| 9053 | In distribution | |
| 9807 | In distribution | |
| 7-8113-10-62-68 | In distribution | |
| 9170 | In distribution | |
| 9803 | In distribution | |
| 9421 | In distribution | |
| 61260T | In distribution | |
| 9694 | In distribution | |
| 61272A | In distribution | |
| 9261 | In distribution | |
| 9636 | In distribution | |
| 7-8113-10-67 | In distribution | |
| 9128 | In distribution | |
| 9812 | In distribution | |
| 9808 | In distribution | |
| 6653 | In distribution | |
| 9246 | In distribution | |
| 9247 | In distribution | |
| 9599 | In distribution | |
| 5610003 | In distribution | |
| 5610002 | In distribution | |
| 51260A-5685 | In distribution | |
| 9096 | In distribution | |
| 9342 | In distribution | |
| 9670 | In distribution | |
| 9691 | In distribution | |
| 9665 | In distribution | |
| 9574 | In distribution | |
| 6754 | In distribution | |
| 9575 | In distribution | |
| 9444 | In distribution | |
| 9110 | In distribution | |
| 9106 | In distribution | |
| 8661 | In distribution | |
| 9805 | In distribution | |
| 8624 | In distribution | |
| 9692 | In distribution | |
| 9298 | In distribution | |
| 8624A | In distribution | |
| 9239 | In distribution | |
| 9801 | In distribution | |
| 9061 | In distribution | |
| 9686 | In distribution | |
| 8025 | In distribution | |
| 8809-W | In distribution | |
| 5610004 | In distribution | |
| 9169 | In distribution | |
| 9060 | In distribution | |
| 9364 | In distribution |
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 |
| 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
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
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.