Safety Adapter
The ADAP 1 is designed to interface between the recessed pin connectors used with Remington's cable models S-101-97, S-201-97, and FL-601-97, and the old models of external pulse generators…
The ADAP 1 is designed to interface between the recessed pin connectors used with Remington’s cable models S-101-97, S-201-97, and FL-601-97, and the old models of external pulse generators (EPG) [old model is the acceptance of exposed 2mm pins]. Also, ADAP I is designed to be used with pacing system analyzers that have sockets that accept 2mm pins and 31.25mm separation between pins.
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 | Remington Medical, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2018-11-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Shipping carton of 25 |
| Sizes | Length 254000000000000 Femtometer; area/surface area 15.204 Square inch |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ADAP II | Length 254000000000000 Femtometer | In distribution |
| ADAP-2RL | Length 254000000000000 Femtometer | In distribution |
| ADAP I | Area/Surface Area 15.204 Square inch | In distribution |
| ADAP-2R | Length 254000000000000 Femtometer | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971968 | 1997-07-23 |
| K922009 | 1993-02-25 |
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 |
|---|---|---|---|---|---|
| 2014-03-05 | Class II | Labeling Change Control | Remington Medical discovered an error on the FL-601-97 IFU; part number IFU-RM-0154. Specifically, the polarity for the black chuck in the picture is wrong. It shows (+), but should show (-). | 41,499 cables | 2018-04-09 |
| 2010-05-19 | Not classified | Process design | The Safe Connect component may separate from the cable, causing the cable to become unplugged from the EPG. | 1488 units | 2010-11-29 |
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.