GEN4 Digital
0800,DPSZ,08,NV,N,TU,TD,RL,RBW,UL,NO Entertainment
1manufacturer
922catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yuiyn HOO Industrial Limited | Dong Guan | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Curbell Medical Products, Inc., United States |
|---|---|
| FDA product code | IQA |
| Device type | System, Environmental Control, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3725 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2020-11-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2020-11-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RPS-5001 | In distribution | |
| 4D19PN-Z100008 | In distribution | |
| 4D010N-Z400008 | In distribution | |
| 4D370U-P004358 | In distribution | |
| 4D215U-P100048 | In distribution | |
| 4D320U-Z10026C | In distribution | |
| 4D370N-Z20580C | In distribution | |
| 4D110N-Z003018 | In distribution | |
| P25104D330U-Z00301C | In distribution | |
| DRPS-5004 | In distribution | |
| 4D235U-Z004008 | In distribution | |
| 4D19JU-Z104098 | In distribution | |
| 4D19BU-Z100028 | In distribution | |
| 4D240U-P10504C | In distribution | |
| 4D310U-P104028 | In distribution | |
| 4D370U-P100088 | In distribution | |
| 4D240U-P105048 | In distribution | |
| 4D080N-Z100168 | In distribution | |
| 4D240U-Z103041 | In distribution | |
| 4D360N-Z003038 | In distribution | |
| 7902 | In distribution | |
| 4D110N-Z000248 | In distribution | |
| 4D010N-Z50004C | In distribution | |
| 4D100U-R100058 | In distribution | |
| 4D320U-P003258 | In distribution | |
| 4D240U-Z104048 | In distribution | |
| 4D080N-R104158 | In distribution | |
| P25104D330U-Z102028 | In distribution | |
| 4D190U-Z000001 | In distribution | |
| 4D190U-R100028 | In distribution | |
| 4D120N-R104028 | In distribution | |
| 4D215U-P103038 | In distribution | |
| 4D190U-R004008 | In distribution | |
| 4D380U-Z000008 | In distribution | |
| 4D320U-Z104368 | In distribution | |
| 4D100U-R000008 | In distribution | |
| 4D370U-Z104348 | In distribution | |
| SF41ZDLE | In distribution | |
| 4D110N-Z100088 | In distribution | |
| 4D330U-R10202C | In distribution | |
| 4D110N-Z015058 | In distribution | |
| 4D320U-P10062J | In distribution | |
| 4D240U-Z100048 | In distribution | |
| SF31ZD10 | In distribution | |
| 4D215U-Z004018 | In distribution | |
| 4D190U-R000008 | In distribution | |
| 4D360N-R102088 | In distribution | |
| 4D290U-P103028 | In distribution | |
| 4D110N-Z000188 | In distribution | |
| 4D290U-Z10002C | In distribution | |
| 4D19JU-Z10409A | In distribution | |
| 4D19JU-Z100098 | In distribution | |
| DRPS-5002 | In distribution | |
| 4D190U-Z10402C | In distribution | |
| 4D320U-P100048 | In distribution | |
| 4D331U-Z102268 | In distribution | |
| 4D240U-P009008 | In distribution | |
| C5512DLP/12 | In distribution | |
| P25104D331U-Z003008 | In distribution | |
| HC-PS-DA2-A | In distribution | |
| 4D19CU-Z500098 | In distribution | |
| 4D19CU-R004008 | In distribution | |
| 4D19BU-Z104028 | In distribution | |
| 6867 | In distribution | |
| 4D110N-Z000038 | In distribution | |
| 4D215U-P004168 | In distribution | |
| 4D100U-Z003018 | In distribution | |
| 4D190U-P003008 | In distribution | |
| 4D19CU-P103158 | In distribution | |
| 4D235U-R104018 | In distribution | |
| 4C291U-Z107008 | In distribution | |
| 4D235U-P104038 | In distribution | |
| 4D330U-Z102278 | In distribution | |
| C5512DLZ | In distribution | |
| 4D215U-Z500108 | In distribution | |
| 4D19JU-Z103138 | In distribution | |
| 4D330U-Z102388 | In distribution | |
| 4D19BU-Z004008 | In distribution | |
| 4D215U-Z100038 | In distribution | |
| 4D210N-R100028 | In distribution | |
| 4D050U-Z10003F | In distribution | |
| 4D331U-Z103028 | In distribution | |
| 4D430U-Z100009 | In distribution | |
| 4D080N-P103128 | In distribution | |
| 4D020N-R500018 | In distribution | |
| 4D19EU-Z004058 | In distribution | |
| 4D190U-P102028 | In distribution | |
| 4D290U-P100028 | In distribution | |
| 4D110N-Z102258 | In distribution | |
| 4D19EN-Z104118 | In distribution | |
| 4D120N-P002018 | In distribution | |
| 4D290U-P002008 | In distribution | |
| 4D320U-P002138 | In distribution | |
| SF41ZDAL10 | In distribution | |
| 4D370U-P004338 | In distribution | |
| 6829 | In distribution | |
| P25104D331U-Z100028 | In distribution | |
| 4D215U-P004028 | In distribution | |
| 4D010N-Z400028 | In distribution | |
| 4D192N-P13737C | In distribution | |
| 4D320U-P00213C | In distribution | |
| P25104D331U-Z005008 | In distribution | |
| 4D360N-Z104238 | In distribution | |
| 4D360N-P102068 | In distribution | |
| 4D19DU-P104028 | In distribution | |
| 4D050U-P100038 | In distribution | |
| 4D190U-P00300A | In distribution | |
| 4D310U-P003018 | In distribution | |
| 4D41BN-101033A | In distribution | |
| 4D055U-R000088 | In distribution | |
| 4D190U-P000008 | In distribution | |
| 4D19PN-0000008 | In distribution | |
| 4D080N-P102068 | In distribution | |
| P25104D331U-Z103028 | In distribution | |
| P25104D330U-Z00000C | In distribution | |
| 4D080N-P000038 | In distribution | |
| 4D320U-P102128 | In distribution | |
| 4D235U-P000008 | In distribution | |
| 4D055U-Z100028 | In distribution | |
| SF31ZDAL | In distribution | |
| 4D330U-P104118 | In distribution | |
| 4D330U-R103028 | In distribution | |
| 4D19EU-Z200008 | In distribution | |
| 4D050U-P104038 | In distribution | |
| 4D310U-P003008 | In distribution | |
| 4D361N-P104198 | In distribution | |
| 4D240U-Z105048 | In distribution | |
| 4D240U-P100058 | In distribution | |
| P25104D330U-Z002008 | In distribution | |
| 4D110N-Z100078 | In distribution | |
| 4D080N-Z000008 | In distribution | |
| 4D370N-Z104748 | In distribution | |
| 4D19EU-Z103028 | In distribution | |
| 4D19PN-Z003028 | In distribution | |
| 4D351N-P103018 | In distribution | |
| 4D010N-R500048 | In distribution | |
| 4D290U-Z004008 | In distribution | |
| 4D360N-R003008 | In distribution | |
| 4D331U-0209028 | In distribution | |
| 4D210N-R104108 | In distribution | |
| 4D190U-0D04028 | In distribution | |
| 4D050U-P000008 | In distribution | |
| 4D370U-P103681 | In distribution | |
| 4D320U-Z104348 | In distribution | |
| 4D370U-P003698 | In distribution | |
| 4D19BU-Z000008 | In distribution | |
| 4D19EU-Z104078 | In distribution | |
| 4D050U-P104028 | In distribution | |
| 4D120N-P100028 | In distribution | |
| 4D190U-Z004001 | In distribution | |
| 4D130N-Z004158 | In distribution | |
| 4D330U-Z102028 | In distribution | |
| 4D370U-R003298 | In distribution | |
| 4D19EU-Z100068 | In distribution | |
| 4D110N-P03718C | In distribution | |
| 4D215U-R100048 | In distribution | |
| 4D19FN-Z000008 | In distribution | |
| 4D190U-Z10002J | In distribution | |
| 4D320U-Z100068 | In distribution | |
| 4D360N-P102228 | In distribution | |
| 4D020N-Z400028 | In distribution | |
| 6828+10 | In distribution | |
| 4D330U-Z00300C | In distribution | |
| 4D215U-Z103038 | In distribution | |
| 4D010N-R500038 | In distribution | |
| 4D360N-R102118 | In distribution | |
| NCPSDSTV | In distribution | |
| 4D235U-P040028 | In distribution | |
| 4D080N-Z100028 | In distribution | |
| 4D235U-P100018 | In distribution | |
| 4D055U-Z104028 | In distribution | |
| 4D320U-Z104328 | In distribution | |
| 4D320U-Z100028 | In distribution | |
| 4D370U-Z00325A | In distribution | |
| 4D010N-Z40001K | In distribution | |
| 4D190U-Z103208 | In distribution | |
| 4D320U-R102088 | In distribution | |
| 4D290U-R104068 | In distribution | |
| 4D370U-P103708 | In distribution | |
| 4D210N-Z104118 | In distribution | |
| 4D190U-P400008 | In distribution | |
| 4D320U-P004338 | In distribution | |
| 4D330U-Z104268 | In distribution | |
| 4D010N-Z50004K | In distribution | |
| 4D020N-P500018 | In distribution | |
| 4D240U-0209048 | In distribution | |
| 4D235U-Z000028 | In distribution | |
| 4D19CU-Z004008 | In distribution | |
| 4D190U-P003548 | In distribution | |
| 4D370U-P103688 | In distribution | |
| 4D430U-ZA0000F | In distribution | |
| 4D230N-Z102058 | In distribution | |
| 4D190U-R008388 | In distribution | |
| 4D230N-Z102018 | In distribution | |
| 4D330U-Z00200C | In distribution | |
| 4D100U-P100048 | In distribution | |
| 4D19CU-Z103128 | In distribution | |
| 4D050U-R000018 | In distribution | |
| 4D19CU-Z100108 | In distribution | |
| 4D320U-R000458 | In distribution | |
| 4D330U-P002018 | In distribution | |
| 4D110N-R104158 | In distribution | |
| 4D290U-Z104078 | In distribution | |
| 4D240U-P100048 | In distribution | |
| 4D215U-P500048 | In distribution | |
| 4D050U-Z100038 | In distribution | |
| 4D050U-Z00400F | In distribution | |
| 4D290U-Z102028 | In distribution | |
| 4D330U-P102028 | In distribution | |
| 4D050U-Z304268 | In distribution | |
| 4D370U-P004258 | In distribution | |
| 4D080N-P000018 | In distribution | |
| 4D370U-Z003318 | In distribution | |
| 4D330U-R000008 | In distribution | |
| 4D330U-P000018 | In distribution | |
| 4D110N-R000028 | In distribution | |
| 4D331U-P102038 | In distribution | |
| 4D320U-Z003178 | In distribution | |
| 4D320U-Z004658 | In distribution | |
| 4D190U-R104028 | In distribution | |
| 4D300N-Z102038 | In distribution | |
| 4D120N-Z004018 | In distribution | |
| 4D300N-R100038 | In distribution | |
| 4D320U-Z003658 | In distribution | |
| 4D210N-Z103028 | In distribution | |
| SF41ZDA | In distribution | |
| 4D310U-Z104028 | In distribution | |
| 4D19RN-R415008 | In distribution | |
| P25104D331U-Z009008 | In distribution | |
| DRPS-5003 | In distribution | |
| 4D011N-0E00018 | In distribution | |
| DRPS-5000 | In distribution | |
| 4D050U-P100028 | In distribution | |
| 4D110N-Z000168 | In distribution | |
| 4D19NN-Z004028 | In distribution | |
| 4D190U-Z00400C | In distribution | |
| 4D320U-P100448 | In distribution | |
| 4D19CU-Z000008 | In distribution | |
| 4D190U-P004008 | In distribution | |
| 4D080N-R103098 | In distribution | |
| 4D210N-Z000008 | In distribution | |
| 4D010N-R400018 | In distribution | |
| 4D19FN-Z103038 | In distribution | |
| 6828+ | In distribution | |
| 4D19EN-Z104128 | In distribution | |
| 4D190U-Z100028 | In distribution | |
| 4D235U-Z039028 | In distribution | |
| 4D370U-Z100048 | In distribution | |
| 4D100U-R003008 | In distribution | |
| 4D380U-Z100048 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEN4 Interactive | Curbell Medical Products, Inc. | 456 |
| GEN4 Plus, Direct Access | Curbell Medical Products, Inc. | 142 |
| Arial | Securitas Healthcare LLC | 96 |
| Ascom | Ascom Sweden AB | 77 |
| Elite Digital | Crest Healthcare Supply | 71 |
| Amplion Care Assurance | Amplion Clinical Communications, Inc. | 67 |
| Elite Infrared | Crest Healthcare Supply | 59 |
| Responder 5, Standard | Curbell Medical Products, Inc. | 33 |
| Excel Digital | Crest Healthcare Supply | 28 |
| Responder 5, Standard,no Entertainment | Curbell Medical Products, Inc. | 28 |
| Excel EntertainIR | Crest Healthcare Supply | 24 |
| GEN4 Direct Access | Curbell Medical Products, Inc. | 23 |
Showing 12 of 819. All products under System, Environmental Control, Powered
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.