Responder 5, Standard
0900,S,10,NV,N,TU,TD,UL,NO Entertainment
1manufacturer
33catalogue 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-562043A | In distribution | |
| 4D410U-101041A | In distribution | |
| 4D412N-100031A | In distribution | |
| 4D410U-162033A | In distribution | |
| 4D41BN-700003A | In distribution | |
| 4D41BN-700393A | In distribution | |
| 4D41BN-764393A | In distribution | |
| 4D410U-101031A | In distribution | |
| 4D41DN-562041A | In distribution | |
| 4D41DN-100033A | In distribution | |
| 4D410U-001040A | In distribution | |
| 4D412N-100033A | In distribution | |
| 4D411U-200400A | In distribution | |
| 4D41BN-562041A | In distribution | |
| 4D41BN-700403A | In distribution | |
| 4D410U-001002A | In distribution | |
| 4D410U-301043A | In distribution | |
| 4D410U-101033A | In distribution | |
| 4D41BN-100043A | In distribution | |
| 4D410U-101031F | In distribution | |
| 4D410U-700031A | In distribution | |
| 4D410U-101043A | In distribution | |
| 4D410U-101003A | In distribution | |
| 4D410U-101001A | In distribution | |
| 4D41BN-563043A | In distribution | |
| 4D410U-001030A | In distribution | |
| 4D410U-1010311 | In distribution | |
| 4D41BN-100041A | In distribution | |
| 4D41BN-764403A | In distribution | |
| 4D41BN-100001A | In distribution | |
| 4D41BN-101041A | In distribution | |
| 4D412N-100001A | In distribution | |
| 4D410U-001000A | 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 |
| 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.