Medical Device Data System
Cbl,netwrk Intrf, 25 RJ45-D9F U/W EPK100
11manufacturers in China registered for this device type
72catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (3), Jiangsu (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Shenzhen Insighters Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Zhejiang Yigao Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Resvent Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
Record
| Listed by | Pentax of America, Inc., United States |
|---|---|
| FDA product code | OUG |
| Device type | Medical Device Data System |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6310 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-03-15 |
| Record revised | 2018-09-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Sizes | Length 6 to 75 ft |
| Distribution end date | 2018-04-02 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| MSSQL-S4 | 4 | In distribution | |
| 92093/25 | Length 25.0 ft | In distribution | |
| KBM68404 | In distribution | ||
| 9267 | In distribution | ||
| 92212/50 | Length 50.0 ft | In distribution | |
| PV-BBVC/25 | Length 25.0 ft | In distribution | |
| 92200/75 | Length 75.0 ft | In distribution | |
| KBM68306 | In distribution | ||
| 9372HD | In distribution | ||
| PV-MVC/6 | Length 6.0 ft | In distribution | |
| KBM68307 | In distribution | ||
| 92204/6 | Length 6.0 ft | In distribution | |
| 92213/25 | Length 25.0 ft | In distribution | |
| 92052/10 | Length 10.0 ft | In distribution | |
| KBM68406 | In distribution | ||
| 9251 | In distribution | ||
| 92215/6 | Length 6.0 ft | In distribution | |
| 68384 | In distribution | ||
| 92205 | In distribution | ||
| KBM68312 | In distribution | ||
| MSSQL-E4 | 4 | In distribution | |
| 90108 | In distribution | ||
| 7251 | In distribution | ||
| KBM68403 | In distribution | ||
| MSSQL-U01 | In distribution | ||
| 92214/12 | Length 12.0 ft | In distribution | |
| 92215/24 | Length 24.0 ft | In distribution | |
| 9263 | In distribution | ||
| 1111-1978 | In distribution | ||
| MSSQL-S8 | 8 | In distribution | |
| 92215/12 | Length 12.0 ft | In distribution | |
| 7190-5300 | In distribution | ||
| 9204 | In distribution | ||
| KBM68311 | In distribution | ||
| MSSQL-E8 | 8 | In distribution | |
| KBM68303 | In distribution | ||
| 92185/6 | Length 6.0 ft | In distribution | |
| 68354 | In distribution | ||
| PV-MVC/15 | Length 15.0 ft | In distribution | |
| 92058 | In distribution | ||
| 7245D | In distribution | ||
| 92093/6 | Length 6.0 ft | In distribution | |
| 92026/6 | Length 6.0 ft | In distribution | |
| 92171/25 | Length 25.0 ft | In distribution | |
| 90138 | In distribution | ||
| PV-BBVC/12 | Length 12.0 ft | In distribution | |
| 9221 | In distribution | ||
| 9269 | In distribution | ||
| 68262 | In distribution | ||
| 92184/6 | Length 6.0 ft | In distribution | |
| 9204HD | In distribution | ||
| MSSQL-UM01A | In distribution | ||
| KBM68407 | In distribution | ||
| 90139 | In distribution | ||
| 92213/6 | Length 6.0 ft | In distribution | |
| 92178 | In distribution | ||
| 9310HD | In distribution | ||
| 1111-1977 | In distribution | ||
| 92215/50 | Length 50.0 ft | In distribution | |
| 68391-ACC | In distribution | ||
| PV-BBVC/6 | Length 6.0 ft | In distribution | |
| 68394 | In distribution | ||
| 92189/12 | Length 12.0 ft | In distribution | |
| 92171/6 | Length 6.0 ft | In distribution | |
| 92171/12 | Length 12.0 ft | In distribution | |
| 92090/25 | Length 25.0 ft | In distribution | |
| PV-MVC/25 | Length 25.0 ft | In distribution | |
| 68403-ACC | In distribution | ||
| 9200D | In distribution | ||
| 92213/12 | Length 12.0 ft | In distribution | |
| 9265 | In distribution | ||
| KBM68401 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Responder | Rauland-Borg Corporation | 170 |
| DreamStation | Respironics Inc. | 55 |
| Endopro IQ | Pentax of America, Inc. | 49 |
| MonitAir | Monitair, LLC | 22 |
| Medical Device Data System | Medtronic, Inc. | 20 |
| DreamMapper | Respironics Inc. | 16 |
| Arthrex® | Arthrex, Inc. | 14 |
| Visionflex | Visionflex PTY Limited | 11 |
| Intesys Clinical Suite | Spacelabs Healthcare (Washington), Inc | 11 |
| myoncare | Oncare GmbH | 9 |
| MicroScan | Beckman Coulter, Inc. | 9 |
| Broadband | Respironics Inc. | 8 |
Showing 12 of 281. All products under Medical Device Data System
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2020-09-22 | Class II | Software design | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially review | 39 total | 2022-05-16 |
| 2020-09-22 | Class II | Software design | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially review | 39 total | 2022-05-16 |
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.