Cardinal Health
KIT, Pediatric Circuit DCH
11manufacturers in China registered for this device type
6catalogue numbers in this listing
14recalls on this code
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 | Cardinal Health 200, LLC, 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, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-08-11 |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 8, case of 24, case of 25, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ANECG7678A | In distribution | |
| AN12142231 | In distribution | |
| SBA40ANVIB | In distribution | |
| ANE3852072 | In distribution | |
| ANE3852071 | In distribution | |
| ANEOC2873A | In distribution |
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 |
| Uni-Lim Coaxial Circuit | Westmed, Inc. | 8 |
Showing 12 of 129. All products under Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Recalls
14 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
| 2013-03-26 | Class I | Packaging process control | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from | 4,571 Kits total | 2017-04-12 |
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.