GEN4 Direct Access
23 catalogue numbers from P25244C331U-Z005038, listed by Curbell Medical Products, Inc., United States, under System, Environmental Control, Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
23catalogue 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 | 2025-01-08 |
| Record revised | 2018-03-29 (version 2) |
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 |
|---|---|---|
| P25244C331U-Z005038 | In distribution | |
| 4C19NN-Z10200C | In distribution | |
| 4C19NN-Z10200A | In distribution | |
| 4C331U-Z10501H | In distribution | |
| P25244C331U-Z105018 | In distribution | |
| 4D216N-P000028 | In distribution | |
| 79054C422U-Z734008 | In distribution | |
| 5C430U-Z3020002F | In distribution | |
| 42217U-Z946048 | In distribution | |
| P25244C330U-P102008 | In distribution | |
| 4C010N-P400028 | In distribution | |
| 4C010N-P400038 | In distribution | |
| P25244C331U-Z103018 | In distribution | |
| 6C382U-Z103008 | In distribution | |
| 4C19EU-Z103038 | In distribution | |
| 4C240U-Z00302A | In distribution | |
| P25244D331U-0209028 | In distribution | |
| P25244C331U-Z003038 | In distribution | |
| 5C430U-Z30200023 | In distribution | |
| 4C360N-Z118488 | In distribution | |
| 4C331U-P134518 | In distribution | |
| P25244C331U-Z140708 | In distribution | |
| 4D216N-P100008 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEN4 Digital | Curbell Medical Products, Inc. | 922 |
| 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 |
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.