Responder
Rauland Responder is a family of nurse-call systems used to connect patients and care teams in healthcare facilities. The Responder III, 3000, IV and 4000 generations supported…
Rauland Responder is a family of nurse-call systems used to connect patients and care teams in healthcare facilities. The Responder III, 3000, IV and 4000 generations supported communication and coordination so staff could receive and respond to calls.
The product name refers to several system generations rather than one device. Rauland identifies these systems as legacy products that are no longer manufactured or supported.
System Generations
Responder III, Responder 3000, Responder IV and Responder 4000 are separate earlier-generation platforms within the family. The manufacturer describes their shared role in healthcare communications.
Current Rauland platforms continue the nurse-call category, but they are distinct products from the legacy Responder systems.
11manufacturers in China registered for this device type
170catalogue numbers in this listing
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 | Rauland-Borg Corporation, United States |
|---|---|
| FDA product code | OUG |
| Device type | Medical Device Data System |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6310 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-11-21 |
| Record revised | 2025-06-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 10 |
| Distribution end date | 2025-06-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R5KMPR15 | In distribution | |
| R5KPB4 | In distribution | |
| HSS433 | In distribution | |
| R4KANNV2 | In distribution | |
| R4KSPK | In distribution | |
| 354020 | In distribution | |
| R5KMSCV3 | In distribution | |
| R5KSSTF | In distribution | |
| R5KL2KAV2 | In distribution | |
| 352023 | In distribution | |
| R4KCAL | In distribution | |
| R5KCANCELV2 | In distribution | |
| 354026 | In distribution | |
| 351006 | In distribution | |
| R5KMPR15GSA | In distribution | |
| R4KPB23 | In distribution | |
| 351206 | In distribution | |
| 353001 | In distribution | |
| 353100 | In distribution | |
| R5KCL546V2 | In distribution | |
| R5KMTRMV2 | In distribution | |
| 351003GSA | In distribution | |
| R5KPS1V | In distribution | |
| R4KSAR | In distribution | |
| HSS401 | In distribution | |
| R5KM8PRT | In distribution | |
| R4K15V | In distribution | |
| 353000 | In distribution | |
| R5KMSCV2 | In distribution | |
| 374400 | In distribution | |
| R5KCL506V2 | In distribution | |
| R5KSDTYV2 | In distribution | |
| 354022 | In distribution | |
| R5KPS1LCAV2 | In distribution | |
| 354001WP | In distribution | |
| 351003 | In distribution | |
| 354028 | In distribution | |
| 354016 | In distribution | |
| R5KMPR36GSA | In distribution | |
| R5KDC46V2 | In distribution | |
| R5KDC16DV2 | In distribution | |
| R4K2JACK | In distribution | |
| R5KPB4V2 | In distribution | |
| R5KSSTFV2 | In distribution | |
| R4K17V | In distribution | |
| R4KMQCV2 | In distribution | |
| 352004 | In distribution | |
| 351011 | In distribution | |
| 350304 | In distribution | |
| 353010 | In distribution | |
| 351008 | In distribution | |
| R5KPB4CNFV2 | In distribution | |
| 354027 | In distribution | |
| 350300 | In distribution | |
| R5KDC016V2 | In distribution | |
| 353101 | In distribution | |
| 354010 | In distribution | |
| R5KAUDPCV2 | In distribution | |
| R4KPB12 | In distribution | |
| R4KPA25 | In distribution | |
| R5KPS1AV2 | In distribution | |
| R5KPC11WPV2 | In distribution | |
| R5KPD2AV2 | In distribution | |
| R5KAUDPC | In distribution | |
| R4KCB13 | In distribution | |
| 351311 | In distribution | |
| R5KPS1EAV2 | In distribution | |
| R5KDC016 | In distribution | |
| 352012 | In distribution | |
| R5KSMSTV2 | In distribution | |
| R5KDC06V2 | In distribution | |
| 354017 | In distribution | |
| R5KCONSV3 | In distribution | |
| R5KMPR36 | In distribution | |
| R5KCONSV2 | In distribution | |
| 351004 | In distribution | |
| 354021 | In distribution | |
| R4KFB1 | In distribution | |
| 354000 | In distribution | |
| 353201 | In distribution | |
| 354025 | In distribution | |
| CLA246 | In distribution | |
| HSS400 | In distribution | |
| 350004 | In distribution | |
| 354001 | Withdrawn | |
| NCLED6 | Withdrawn | |
| CLV144 | Withdrawn | |
| R5KDC46 | Withdrawn | |
| CLA222 | Withdrawn | |
| NCNSCB | Withdrawn | |
| R5KMRAPID | Withdrawn | |
| 350034 | Withdrawn | |
| NCLCD | Withdrawn | |
| 354011 | Withdrawn | |
| 353200 | Withdrawn | |
| R4K11V | Withdrawn | |
| R4KESR | Withdrawn | |
| 354018 | Withdrawn | |
| 351001 | Withdrawn | |
| 352010 | Withdrawn | |
| R5KCL516 | Withdrawn | |
| R5KPS1EA | Withdrawn | |
| R5KPS1LCA | Withdrawn | |
| 301103 | Withdrawn | |
| R5KCL506 | Withdrawn | |
| R4K13VA | Withdrawn | |
| R4K23VA | Withdrawn | |
| R4KPC10 | Withdrawn | |
| R4KSS | Withdrawn | |
| 351310 | Withdrawn | |
| R5KPD2A | Withdrawn | |
| NCBSS1 | Withdrawn | |
| R5KANN | Withdrawn | |
| 351205 | Withdrawn | |
| CLV122 | Withdrawn | |
| R4K16LV | Withdrawn | |
| NCPBPH | Withdrawn | |
| R4K21V | Withdrawn | |
| R4KCNCL | Withdrawn | |
| R4KPC11 | Withdrawn | |
| 351000 | Withdrawn | |
| DCV116 | Withdrawn | |
| 351300 | Withdrawn | |
| 352000 | Withdrawn | |
| R4K12A | Withdrawn | |
| R5KCONS | Withdrawn | |
| R5KURTA | Withdrawn | |
| R5KPPS | Withdrawn | |
| R5KPC11WP | Withdrawn | |
| R5KUPS1 | Withdrawn | |
| 354002 | Withdrawn | |
| R4KDY | Withdrawn | |
| R5KSDTY | Withdrawn | |
| R5KDC06 | Withdrawn | |
| NCSPB1 | Withdrawn | |
| R4K14SA | Withdrawn | |
| NCBSD2 | Withdrawn | |
| DCA200 | Withdrawn | |
| R4KPB11 | Withdrawn | |
| R4K4020 | Withdrawn | |
| DCA214D | Withdrawn | |
| R4KDTY2 | Withdrawn | |
| 354015 | Withdrawn | |
| R4KSR1 | Withdrawn | |
| R4K22A | Withdrawn | |
| NCUINT | Withdrawn | |
| 352021 | Withdrawn | |
| NCPCS1 | Withdrawn | |
| R4KPR400 | Withdrawn | |
| R4KPB22 | Withdrawn | |
| 354012 | Withdrawn | |
| R5KDC16D | Withdrawn | |
| NCPWR | Withdrawn | |
| R4KCB12 | Withdrawn | |
| R5KPD2EA | Withdrawn | |
| R5KSMST | Withdrawn | |
| R5KUPB2 | Withdrawn | |
| DCV100 | Withdrawn | |
| R4KPB44 | Withdrawn | |
| NCBACB | Withdrawn | |
| R5KUCNL | Withdrawn | |
| NCGCM | Withdrawn | |
| NCDPB2 | Withdrawn | |
| NCDUTY | Withdrawn | |
| R5KCL546 | Withdrawn | |
| 3225300 | Withdrawn | |
| CLA244 | Withdrawn | |
| NCUS1 | Withdrawn | |
| R5KPS1A | Withdrawn | |
| DCA216 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Device Data System | Pentax of America, Inc. | 72 |
| 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
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.