DeRoyal
Anesth. KIT Center FOR Plastic Surgery
11manufacturers in China registered for this device type
38catalogue numbers in this listing
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 | Deroyal Industries, 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-28 |
| Record revised | 2022-10-24 (version 2) |
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 | Case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 86-001816 | In distribution | |
| 86-001698 | In distribution | |
| 86-001825 | In distribution | |
| 86-001682 | In distribution | |
| 86-001641 | In distribution | |
| 86-003550 | In distribution | |
| 86-001726 | In distribution | |
| 82-2014010 | In distribution | |
| 86-001801 | In distribution | |
| 86-000993 | In distribution | |
| 86-001820 | In distribution | |
| 8N-000782 | In distribution | |
| 86-001807 | In distribution | |
| 86-001802 | In distribution | |
| 86-001513 | In distribution | |
| 86-001725 | In distribution | |
| 86-001619 | In distribution | |
| 8N-001618 | In distribution | |
| 86-000413 | In distribution | |
| 86-001812 | In distribution | |
| 86-000412 | In distribution | |
| 86-001519 | In distribution | |
| 86-001776 | In distribution | |
| 86-001762 | In distribution | |
| 82-2010030 | In distribution | |
| 86-001669 | In distribution | |
| 82-0083230 | In distribution | |
| 82-2011330 | In distribution | |
| 82-2013131 | In distribution | |
| 82-2003131 | In distribution | |
| 86-001831 | In distribution | |
| 86-001821 | In distribution | |
| 86-001830 | In distribution | |
| 82-2014111 | In distribution | |
| 86-001673 | In distribution | |
| 86-001781 | In distribution | |
| 86-001829 | In distribution | |
| 86-001822 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AirLife™ | Airlife, Inc. | 75 |
| Disposable anesthesia circuits | Westmed, Inc. | 73 |
| 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.