Responder 5, Standard,no Entertainment
Responder 5, Standard, NO Entertainment
1manufacturer
28catalogue 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 | 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 |
|---|---|---|
| 4D41DN-100001A | In distribution | |
| 4D41EN-975412A | In distribution | |
| 4D411U-200060A | In distribution | |
| 4D41DN-100041A | In distribution | |
| 4D41EN-504040A | In distribution | |
| 4D411U-001032A | In distribution | |
| 4D411U-201030A | In distribution | |
| 4D411U-001391A | In distribution | |
| 4D41CN-501040A | In distribution | |
| 4D41CN-504040A | In distribution | |
| 4D41CN-563040A | In distribution | |
| 4D411U-200040A | In distribution | |
| 4D411U-201040A | In distribution | |
| 4D41EN-563000A | In distribution | |
| 4D411U-201000A | In distribution | |
| 4D41EN-968412A | In distribution | |
| 4D41EN-562040A | In distribution | |
| 4D41EN-501040A | In distribution | |
| 4D411U-200030A | In distribution | |
| 4D411U-200000A | In distribution | |
| 4D411U-765000A | In distribution | |
| 4D41DN-101041A | In distribution | |
| 4D41DN-563043A | In distribution | |
| 4D411U-201000F | In distribution | |
| 4D411U-001031A | In distribution | |
| 4D41EN-563040A | In distribution | |
| 4D41CN-562040A | In distribution | |
| 4D411U-001002A | 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 |
| 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.