GEN4 Plus, Responder 5, Standard
33 catalogue numbers from 5D411U-20100000F, listed by Curbell Medical Products, Inc., United States, under System, Communication, Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
33catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Contin Medical Device Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Curbell Medical Products, Inc., United States |
|---|---|
| FDA product code | ILQ |
| Device type | System, Communication, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3710 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-04-26 |
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 |
|---|---|---|
| 5D411U-20100000F | In distribution | |
| 5D411U-00100002A | In distribution | |
| 5D41BN-10000001A | In distribution | |
| 5D411U-20040000A | In distribution | |
| 5D410U-10104003A | In distribution | |
| 5D410U-00103002A | In distribution | |
| 5D411U-76500000A | In distribution | |
| 5D41BN-56204001A | In distribution | |
| 5D411U-00103001A | In distribution | |
| 5D410U-10103001A | In distribution | |
| 5D410U-00103000A | In distribution | |
| 5D41EN-50104000A | In distribution | |
| 5D410U-10100001A | In distribution | |
| 5D410U-00104000A | In distribution | |
| 5D411U-20004000A | In distribution | |
| 5D410U-101030011 | In distribution | |
| 5D41EN-56304000A | In distribution | |
| 5D411U-20100000A | In distribution | |
| 5D411U-20104000A | In distribution | |
| 5D410U-00100000A | In distribution | |
| 5D41BN-10103003A | In distribution | |
| 5D411U-20103000F | In distribution | |
| 5D41BN-56204003A | In distribution | |
| 5D410U-10103003A | In distribution | |
| 5D410U-10104001A | In distribution | |
| 5D412N-10000001A | In distribution | |
| 5D410U-30104003A | In distribution | |
| 5D412N-10003001A | In distribution | |
| 5D410U-10100003A | In distribution | |
| 5D412N-10003003A | In distribution | |
| 5D411U-20103000A | In distribution | |
| 5D411U-00103002A | In distribution | |
| 5D410U-00100002A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GEN4 Direct Access | Curbell Medical Products, Inc. | 1,343 |
| GEN4 Interactive | Curbell Medical Products, Inc. | 1,005 |
| GEN4 Plus, Direct Access | Curbell Medical Products, Inc. | 599 |
| Responder 5, Interactive | Curbell Medical Products, Inc. | 573 |
| Series 8 Anacom MedTek | Anacom Medtek | 519 |
| Series 7 Anacom MedTek | Anacom Medtek | 312 |
| GEN4 Plus, Responder 5, Enhanced | Curbell Medical Products, Inc. | 112 |
| Responder 5, Enhanced | Curbell Medical Products, Inc. | 108 |
| Tobii Dynavox | Tobii Dynavox LLC | 44 |
| Nova Chat | Prentke Romich Co. | 44 |
| Saltillo | Prentke Romich Co. | 27 |
| NovaChat | Prentke Romich Co. | 22 |
Showing 12 of 1,439. All products under System, Communication, 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.