Connector
70 catalogue numbers from AX-xxxxx, listed by LivaNova USA, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
70catalogue numbers in this listing
23recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Record
| Listed by | LivaNova USA, Inc., United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K833322 |
| Record published | 2015-07-16 |
| Record revised | 2018-08-15 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 24, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution | |
| AX-xxxxx | In distribution | |
| Connector | In distribution | |
| AX-xxxxx | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Medline Industries, Inc. | 170 |
| Namic | Navilyst Medical, Inc. | 165 |
| Merit® Manifold | Merit Medical Systems, Inc. | 119 |
| Medline Industries, Inc. | Medline Industries, Inc. | 62 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 60 |
| DLP® | Medtronic, Inc. | 51 |
| Marquis® Stopcock | Merit Medical Systems, Inc. | 40 |
| Cook | Cook Incorporated | 38 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| Contrast Line | Argon Medical Devices, Inc. | 25 |
| INT | Shanghai Kindly Medical Instruments Co., Ltd. | 18 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Recalls Naming This Product
22 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 120 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 24 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 24 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 48 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 48 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 72 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 648 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 96 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 600 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 96 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 744 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 984 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 768 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 240 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 20 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | XXX | 220 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 860 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 420 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 240 units | 2022-02-17 |
| LivaNova USA, Inc. | 510(k) number | 2019-11-18 | Class III | Packaging process control | Some packages of sterile disposable connectors contained a 3/8×1/4 reducer instead of the specified 1/2×1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of | 140 units | 2021-08-19 |
| LivaNova USA, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. | 1,640 units | 2013-04-23 |
| LivaNova USA, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. | 1,380 units | 2013-04-23 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 24 units | 2022-02-17 |
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.