Uni-Lim Coaxial Circuit
Anesthesia Circuit, Adult, Uni-lim, 60" Coaxial, w/24" flex expiatory lead, Inner Elbow w/GSP, In-Line Mini HMEF, Large adult mask with 10' suction tubing, 3L not made with latex bag, 10' x…
Anesthesia Circuit, Adult, Uni-lim, 60″ Coaxial, w/24″ flex expiatory lead, Inner Elbow w/GSP, In-Line Mini HMEF, Large adult mask with 10′ suction tubing, 3L not made with latex bag, 10′ x.050″ ID M/M GSL, non vented non sterile yankauer
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 | 2024-02-07 |
| Record revised | 2023-08-04 (version 6) |
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, serial number |
| Packaging | Pack of 20, case of 20, pack of 10 |
| Distribution end date | 2023-08-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8126 | In distribution | |
| 8809-W | In distribution | |
| 9415 | In distribution | |
| 9416 | In distribution | |
| 9566 | In distribution | |
| 9432 | In distribution | |
| 9615 | Withdrawn | |
| 9626 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife™ | Airlife, Inc. | 75 |
| Disposable anesthesia circuits | Westmed, Inc. | 73 |
| 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 |
| 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.