Disposable Anesthesia Circuits
Anesthesia Circuit, Adult, 108" Expandable, Parallel Wye, B/V Filter, (2) GSE w/Cap, 2L Not made with latex bag, 10' x .038" ID m/M GSL w/Swivel elbow, 9910 series large adult mask, 10'…
Anesthesia Circuit, Adult, 108″ Expandable, Parallel Wye, B/V Filter, (2) GSE w/Cap, 2L Not made with latex bag, 10′ x.038″ ID m/M GSL w/Swivel elbow, 9910 series large adult mask, 10′ section tubing. Yankauer Sterile
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Zhejiang Haisheng Medical Device Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 21 |
| Ningbo Huakun Medical Equipment Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 19 |
| Shandong Jinlai Huanhai Medical Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 19 |
| Hangzhou Shanyou Medical Equipment Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 17 |
| Excellentcare Medical (Huizhou) Ltd. | Huizhou | Guangdong | Manufacturer | 14 |
| Shaoxing Reborn Medical Devices Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 14 |
| Ningbo Runmai Medical Technology Co., Ltd. | Cixi | Zhejiang | Repacker / relabeller | 7 |
Record
| Listed by | Westmed, Inc., United States |
|---|---|
| FDA product code | OFP |
| Device type | Anesthesia Breathing Circuit Kit (Adult & Pediatric) |
| Device class | Class 1 |
| Regulation | 21 CFR 868.5240 |
| Establishment | Contract manufacturer, Remanufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K922492 |
| Record published | 2017-10-26 |
| Record revised | 2024-02-01 (version 8) |
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 |
| Packaging | Pack of 20, pack of 10, pack of 30, pack of 15, pack of 50 |
| Distribution end date | 2024-05-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9359 | In distribution | |
| 9051 | In distribution | |
| 7-8413-10-62 | In distribution | |
| 8601 | In distribution | |
| 5705 | In distribution | |
| 8613 | In distribution | |
| 8833 | In distribution | |
| 9148 | In distribution | |
| 6844 | In distribution | |
| 9270 | In distribution | |
| 9033 | In distribution | |
| 9625 | In distribution | |
| 41212-1NV | In distribution | |
| 8012 | In distribution | |
| 5705 MX | In distribution | |
| 9302 | In distribution | |
| 8822 | In distribution | |
| 8970 | In distribution | |
| 9053 | In distribution | |
| 61272ARW | In distribution | |
| 9623 | In distribution | |
| 9575 | In distribution | |
| 7-8901 | In distribution | |
| 6723 | In distribution | |
| 7-8403-10-62 | In distribution | |
| 9323 | In distribution | |
| 7-8901-10-62 | In distribution | |
| 7-8901-10-62-69 | In distribution | |
| 7-8103-10 | In distribution | |
| 8139 | In distribution | |
| 9046 | In distribution | |
| 8024 | In distribution | |
| 7-9201-10-62 | In distribution | |
| 9335 | In distribution | |
| 7-8113-10 | In distribution | |
| 8029 | In distribution | |
| 9316 | In distribution | |
| 9344 | In distribution | |
| 8626 | In distribution | |
| 7-9201-10 | In distribution | |
| 9119 | In distribution | |
| 9273 | In distribution | |
| 9596 | In distribution | |
| 7-8901-10-69 | In distribution | |
| 8090 | In distribution | |
| 9574 | In distribution | |
| 9358 | In distribution | |
| 9280 | In distribution | |
| 9045 | In distribution | |
| 9417 | In distribution | |
| 9324 | Withdrawn | |
| 9422 | Withdrawn | |
| 7-7201-66 | Withdrawn | |
| 8677 | Withdrawn | |
| 9050 | Withdrawn | |
| 7-7205-66 | Withdrawn | |
| N1332 | Withdrawn | |
| 8047 | Withdrawn | |
| 7-7103-66 | Withdrawn | |
| 7-8303-10 | Withdrawn | |
| CA3107 | Withdrawn | |
| 7-7102-66 | Withdrawn | |
| 9147 | Withdrawn | |
| 8279 | Withdrawn | |
| 9681 | Withdrawn | |
| 6719 | Withdrawn | |
| 8042 | Withdrawn | |
| 7-7105-66 | Withdrawn | |
| 7-7202-66 | Withdrawn | |
| 6015 | Withdrawn | |
| 7-7101-66 | Withdrawn | |
| 7350 | Withdrawn | |
| 8065 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife™ | Airlife, Inc. | 75 |
| DeRoyal | Deroyal Industries, Inc. | 38 |
| Vital Signs™ | Airlife, Inc. | 31 |
| Medline Industries, Inc. | Medline Industries, Inc. | 30 |
| AirLife™ | Vyaire Medical, Inc. | 18 |
| Disposable Anesthesia Circuit | Westmed, Inc. | 17 |
| Anesthesia Circuit Kit | Westmed, Inc. | 11 |
| Simple Solutions Medical | Simple Solutions Medical | 10 |
| Vital Signs™ | Vyaire Medical, Inc. | 8 |
| Vital Signs™ | AirLife Finland Oy | 8 |
| Uni-Lim Coaxial Circuit | Westmed, Inc. | 8 |
| Disposable Respiratory Circuits | Westmed, Inc. | 7 |
Showing 12 of 129. All products under Anesthesia Breathing Circuit Kit (Adult & Pediatric)
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.