GEN4 Plus, Direct Access
2020,DACZ,08,DV,N,LT,VN,RYL,UL,MIC, LT ON Pins 2 & 3
1manufacturer
599catalogue 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 | 2019-05-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2022-04-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5C370U-P10000BA8 | In distribution | |
| 5C331U-Z10500018 | In distribution | |
| 5C010N-R50001018 | In distribution | |
| 5C290U-Z10000018 | In distribution | |
| 5C330U-Z02100608 | In distribution | |
| 4C331U-P157018 | In distribution | |
| 5C120N-Z10400048 | In distribution | |
| 5C310U-Z00400028 | In distribution | |
| 5C330U-Z00300028 | In distribution | |
| 5C331U-Z15300508 | In distribution | |
| 5C190U-Z1030003C | In distribution | |
| 5C360N-Z10300378 | In distribution | |
| 5C310U-Z10400048 | In distribution | |
| 5C240U-Z10300008 | In distribution | |
| 5C100U-P00000048 | In distribution | |
| 5C190U-Z10000038 | In distribution | |
| 5C290U-Z00000068 | In distribution | |
| 5C290U-P10400048 | In distribution | |
| 5C235U-Z00000008 | In distribution | |
| 5C330U-Z05400728 | In distribution | |
| 5C370U-Z11900BMA | In distribution | |
| 5C331U-Z0030002C | In distribution | |
| 5C235U-P1030003C | In distribution | |
| 5C331U-Z14300018 | In distribution | |
| 5C380U-Z1030001C | In distribution | |
| 5C19AN-Z0030003C | In distribution | |
| 5C300N-Z00300018 | In distribution | |
| 5C110N-Z00000118 | In distribution | |
| 5C010N-P50001018 | In distribution | |
| 5C100U-Z00000048 | In distribution | |
| 5C010N-Z40001028 | In distribution | |
| 5C190U-P1040002C | In distribution | |
| 5C360N-P10300098 | In distribution | |
| 5C380U-Z16900008 | In distribution | |
| 5C320U-Z00300BB8 | In distribution | |
| 5C330U-Z13400708 | In distribution | |
| 5C240U-P10500018 | In distribution | |
| 5C320U-Z10000BC8 | In distribution | |
| 5C242U-Z11500008 | In distribution | |
| 5C380U-Z10300018 | In distribution | |
| 5C370U-R10300BE8 | In distribution | |
| 5C290U-Z10300018 | In distribution | |
| 5C020N-Z50001038 | In distribution | |
| 5C300N-Z10000038 | In distribution | |
| 5C331U-Z10500011 | In distribution | |
| 5C235U-Z1030001F | In distribution | |
| 5C380U-Z10500008 | In distribution | |
| 5C240U-Z10000048 | In distribution | |
| 5C330U-P00300388 | In distribution | |
| 5C370U-Z10000BA8 | In distribution | |
| 5C110N-Z10000038 | In distribution | |
| 5C243U-Z11500088 | In distribution | |
| 5C330U-Z10300008 | In distribution | |
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| 5C350N-Z11800128 | In distribution | |
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| 5C370U-P10400BC8 | In distribution | |
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| 5C215U-Z10000018 | In distribution | |
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| 5C370U-Z10300BE8 | In distribution | |
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| 5C130N-Z10400118 | In distribution | |
| 5C215U-Z10000008 | In distribution | |
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| 5C310U-Z10400018 | In distribution | |
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| 5C190U-P11500038 | In distribution | |
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| 5C215U-P10000008 | In distribution | |
| 5C331U-P00500028 | In distribution | |
| 5C330U-Z00300038 | In distribution | |
| 5C050U-Z00400028 | In distribution | |
| 5C190U-P13400368 | In distribution | |
| 5C290U-P10000008 | In distribution | |
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| 5C021N-Z10000018 | In distribution | |
| 5C330U-P12100588 | In distribution | |
| 5C050U-P00000028 | In distribution | |
| 5C190U-R00000008 | In distribution | |
| 5C330U-Z00300268 | In distribution | |
| 5C190U-P10300031 | In distribution | |
| 5C320U-P10400BC8 | In distribution | |
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| 5C210N-Z10000038 | In distribution | |
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| 5C360N-Z10300228 | In distribution | |
| 5C370U-P10300BE8 | In distribution | |
| 5C120N-P10000048 | In distribution | |
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| 5C360N-Z10400118 | In distribution | |
| 5C360N-Z10400088 | In distribution | |
| 5C100U-Z00400228 | In distribution | |
| 5C320U-Z10400BR8 | In distribution | |
| 5C330U-Z00000028 | In distribution | |
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| 5C19RU-Z10000008 | In distribution | |
| 5C235U-P10000018 | In distribution | |
| 5C290U-Z1030000C | In distribution | |
| 5C190U-P1030002F | In distribution | |
| 5C230N-P10400018 | In distribution | |
| 5C215U-Z10400018 | In distribution | |
| 5C020N-P40001008 | In distribution | |
| 5C331U-Z1190070A | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| GEN4 Plus, Responder 5, Standard | Curbell Medical Products, Inc. | 33 |
| 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.