GEN4 Plus, Direct Access
142 catalogue numbers from 5C19FN-Z10300008, listed by Curbell Medical Products, Inc., United States, under System, Environmental Control, Powered. 1 manufacturer in China is registered for this product code.
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 | 2019-04-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5C19FN-Z10300008 | In distribution | |
| 5C331U-Z00500038 | In distribution | |
| 5C19EU-Z10300028 | In distribution | |
| 5C19DU-Z10400028 | In distribution | |
| 5C331U-Z05600538 | In distribution | |
| 5C330U-Z10300011 | In distribution | |
| 5C383U-Z10300008 | In distribution | |
| 5C190U-Z11500488 | In distribution | |
| 5C331U-Z16000588 | In distribution | |
| 5C19DU-Z11900128 | In distribution | |
| 5C380U-Z10500011 | In distribution | |
| 5C331U-Z05800528 | In distribution | |
| 5C331U-Z1000000A | In distribution | |
| 5C190U-Z10400038 | In distribution | |
| 5C190U-ZD0300028 | In distribution | |
| 5C422U-Z12700028 | In distribution | |
| 5C331U-Z5000100C | In distribution | |
| 5C19CU-P10400008 | In distribution | |
| 5C331U-Z16909838 | In distribution | |
| 5C19FN-P10300008 | In distribution | |
| 5C190U-Z1080040C | In distribution | |
| 5C331U-Z10300008 | In distribution | |
| 5C331U-Z0050403C | In distribution | |
| 5C331U-Z10300001 | In distribution | |
| 5C193U-Z00300018 | In distribution | |
| 5C19AN-Z10300008 | In distribution | |
| 5C331U-Z1030001C | In distribution | |
| 5C430U-Z3020000F | In distribution | |
| 5C19EU-Z10000038 | In distribution | |
| 5C19CU-Z10300048 | In distribution | |
| 5C19CU-Z10300068 | In distribution | |
| 5C421U-Z1030600F | In distribution | |
| 5C19CU-Z10000008 | In distribution | |
| 5C050U-P10000288 | In distribution | |
| 5C19CU-Z00000088 | In distribution | |
| 5C331U-Z00900028 | In distribution | |
| 5C331U-Z01900078 | In distribution | |
| 5C19DU-P10000028 | In distribution | |
| 5C190U-Z1040002F | In distribution | |
| 5C421U-Z1030000C | In distribution | |
| 5C19CU-Z10300058 | In distribution | |
| 5C19CU-P10400028 | In distribution | |
| 5C190U-Z11800448 | In distribution | |
| 5C19DU-Z10000028 | In distribution | |
| 5C19AN-Z10000018 | In distribution | |
| 5C190U-Z16000248 | In distribution | |
| 5C190U-Z11600378 | In distribution | |
| 5C240U-Z1000000C | In distribution | |
| 5C19TU-Z13100008 | In distribution | |
| 5C383U-Z10700008 | In distribution | |
| 5C19CU-Z10000038 | In distribution | |
| 5C19EU-P10400038 | In distribution | |
| 5C331U-Z10000001 | In distribution | |
| 5C331U-Z10000018 | In distribution | |
| 5C19DU-Z10000038 | In distribution | |
| 5C331U-Z10000008 | In distribution | |
| 5C331U-Z15600838 | In distribution | |
| 5C331U-Z1640001C | In distribution | |
| 5C19CU-Z10400008 | In distribution | |
| 5C331U-Z06500538 | In distribution | |
| 5C19TU-Z10900008 | In distribution | |
| 5C331U-Z1550051C | In distribution | |
| 5C19FN-Z1030000C | In distribution | |
| 5C19DU-Z00300068 | In distribution | |
| 5C331U-Z16300018 | In distribution | |
| 5C331U-Z16200018 | In distribution | |
| 5C19AN-Z0030002C | In distribution | |
| 5C190U-Z12300028 | In distribution | |
| 5C19CU-Z16900048 | In distribution | |
| 5C331U-Z10400018 | In distribution | |
| 5C19DN-Z1040020C | In distribution | |
| 5C331U-Z01900028 | In distribution | |
| 5C331U-Z1050001H | In distribution | |
| 5C331U-Z16800048 | In distribution | |
| 5C19AN-Z00300028 | In distribution | |
| 5C331U-Z0050503C | In distribution | |
| 5C19CU-P10300048 | In distribution | |
| 5C331U-Z10300258 | In distribution | |
| 5C19AN-Z10300018 | In distribution | |
| 5C19FN-Z00300028 | In distribution | |
| 5C331U-Z16400008 | In distribution | |
| 5C19EU-P00000008 | In distribution | |
| 5C331U-Z15900588 | In distribution | |
| 5C19CU-P10000028 | In distribution | |
| 5C331U-Z01900038 | In distribution | |
| 5C331U-Z00500028 | In distribution | |
| 5C380U-Z10500001 | In distribution | |
| 5C190U-Z90000028 | In distribution | |
| 5C331U-P11900018 | In distribution | |
| 5C19EU-Z10400028 | In distribution | |
| 5C331U-Z16400018 | In distribution | |
| 5C19DU-Z10400038 | In distribution | |
| 5C19EU-P10000028 | In distribution | |
| 5C430U-Z30200001 | In distribution | |
| 5C19AN-Z00000038 | In distribution | |
| 5C19EU-Z10000028 | In distribution | |
| 5C430U-Z30000029 | In distribution | |
| 5C331U-Z16900018 | In distribution | |
| 5C19AN-Z00000028 | In distribution | |
| 5C331U-P16300018 | In distribution | |
| 5C331U-Z10300798 | In distribution | |
| 5C19CU-Z10400038 | In distribution | |
| 5C331U-Z0050003C | In distribution | |
| 5C190U-Z11700368 | In distribution | |
| 5C19EU-P10400028 | In distribution | |
| 5C19DU-Z15900178 | In distribution | |
| 5C190U-P1030702F | In distribution | |
| 5C19CU-Z10000018 | In distribution | |
| 5C190U-Z15300368 | In distribution | |
| 5C19BU-Z10400008 | In distribution | |
| 5C331U-Z0050403H | In distribution | |
| 5C19CU-Z10000028 | In distribution | |
| 5C19DU-Z17200168 | In distribution | |
| 5C331U-R10300018 | In distribution | |
| 5C19DU-Z10300048 | In distribution | |
| 5C331U-Z05600858 | In distribution | |
| 5C19DU-Z15900058 | In distribution | |
| 5C19BU-P10000028 | In distribution | |
| 5C19CU-P10000018 | In distribution | |
| 5C19DU-P10400028 | In distribution | |
| 5C331U-P10500008 | In distribution | |
| 5C331U-Z10300018 | In distribution | |
| 5C19UN-Z10400008 | In distribution | |
| 5C19JU-Z10300071 | In distribution | |
| 5C19BU-Z10000008 | In distribution | |
| 5C19UN-Z10400018 | In distribution | |
| 5C330U-Z51708808 | In distribution | |
| 5C19AN-Z10000008 | In distribution | |
| 5C331U-R16700018 | In distribution | |
| 5C19DN-Z1100016C | In distribution | |
| 5C19EU-Z00000018 | In distribution | |
| 5C190U-Z10800408 | In distribution | |
| 5C331U-P10900008 | In distribution | |
| 6C242U-Z103008 | In distribution | |
| 5C19TU-Z03100038 | In distribution | |
| 5C331U-P1450070A | In distribution | |
| 5C19FN-Z10400018 | In distribution | |
| 5C331U-Z16500508 | In distribution | |
| 5C19FN-Z10000008 | In distribution | |
| 5C190U-Z11600368 | In distribution | |
| 5C380U-Z10500001 | In distribution | |
| 5C420U-Z1000000A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEN4 Digital | Curbell Medical Products, Inc. | 922 |
| GEN4 Interactive | Curbell Medical Products, Inc. | 456 |
| 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.