IBP Y-Cable 16p TO 10 Pin
Catalogue number 5731281, listed by Draeger Medical Systems, Inc., United States, under Cable, Transducer And Electrode, Patient, (Including Connector). 22 manufacturers in China are registered for this product code.
22manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (1), Zhejiang (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Ningbo Xinwell Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 12 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| ABA Medical Technology Co Ltd | Guang Dong | Guangdong | Contract manufacturer | 6 |
| Beijing Rongrui Century Science Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 4 |
| Dongguan Rongrui-Century Science&Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Ruibaolian Medical Science & Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Dongguan Kepler Special Cabling Company Limited | Dongguan | Guangdong | Contract manufacturer | 3 |
| Palconn Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| Shenzhen Redy-MED Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Showing 12 of 22. All 22 manufacturers in China registered for Cable, Transducer And Electrode, Patient, (Including Connector)
Record
| Listed by | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | DSA |
| Device type | Cable, Transducer And Electrode, Patient, (Including Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2900 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K070566 |
| Record published | 2015-10-24 |
| Record revised | 2023-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5731281 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Unimed | Unimed Medical Supplies Inc | 5,928 |
| AMC | LifeSync Corporation | 1,058 |
| Fogg System Company, Inc. | Fogg System Company, Inc. | 693 |
| Multi-Link™ | AirLife Finland Oy | 611 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | ConMed Corporation | 284 |
| Maguire | Maguire Enterprises, Inc. | 193 |
| MediChoice | Owens & Minor Distribution, Inc. | 160 |
| Vermed | Graphic Controls Acquisition Corporation | 159 |
| Vital Signs™ | AirLife Finland Oy | 136 |
| Multi-Link™ | Carefusion Finland 320 Oy | 136 |
| Med-link | Shenzhen MED-Link Electronics Tech Co., Ltd. | 129 |
| Conmed | ConMed Corporation | 106 |
Showing 12 of 1,260. All products under Cable, Transducer And Electrode, Patient, (Including Connector)
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Draeger, Inc. | 510(k) number | 2011-10-31 | Not classified | Software design | Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements. | 14,894 | 2013-07-01 |
| Draeger Medical Systems, Inc. | 510(k) number | 2011-07-29 | Not classified | Device Design | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. | 32 | 2012-08-16 |
| Draeger Medical Systems, Inc. | 510(k) number | 2011-07-29 | Not classified | Device Design | Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically. | 29 | 2012-08-16 |
| Draeger Medical Systems, Inc. | 510(k) number | 2010-06-04 | Not classified | Device Design | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. | 8675 units | 2012-07-30 |
| Draeger Medical Systems, Inc. | 510(k) number | 2010-06-04 | Not classified | Device Design | Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically. | 800 units | 2012-07-30 |
| Draeger, Inc. | 510(k) number | 2009-11-09 | Not classified | Software design | monitor is rebooting/resetting | 4,188 units | 2011-08-23 |
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.