GEN4 Direct Access
1012,DACZ,08,AV,WCNCW,N,PM,WT,BP,UL,PV
1manufacturer
1,343catalogue 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 | 2016-09-24 |
| Record revised | 2020-01-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2020-11-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4C19NN-Z100008 | In distribution | |
| 4C120N-Z103108 | In distribution | |
| 4C050U-P000028 | In distribution | |
| 4C080N-R103028 | In distribution | |
| 4C330U-Z000028 | In distribution | |
| 4C080N-P000008 | In distribution | |
| 4C310U-P104008 | In distribution | |
| 4C370U-P110688 | In distribution | |
| DARPS-5002 | In distribution | |
| 4C193U-Z003018 | In distribution | |
| 4C240U-Z00002C | In distribution | |
| 4C331U-Z94401C | In distribution | |
| 4C190U-Z216028 | In distribution | |
| 4C331U-Z11970C | In distribution | |
| 4C19EU-P104038 | In distribution | |
| 4C330U-Z103018 | In distribution | |
| 4C19CU-Z100008 | In distribution | |
| 4C215U-Z104018 | In distribution | |
| 4C360U-Z135128 | In distribution | |
| 4C360N-Z103080 | In distribution | |
| 4C330U-P104258 | In distribution | |
| 4C360N-P104068 | In distribution | |
| 4C330U-Z15471C | In distribution | |
| 4C330U-Z103248 | In distribution | |
| 4C080N-Z003018 | In distribution | |
| 4C190U-Z100021 | In distribution | |
| 4C190U-Z103020 | In distribution | |
| 4C100U-Z102028 | In distribution | |
| 4C380U-Z10301C | In distribution | |
| 4C230N-Z100038 | In distribution | |
| 4C235U-Z100018 | In distribution | |
| 4C100U-Z103008 | In distribution | |
| 4C19AN-Z10404C | In distribution | |
| 4C055U-P100008 | In distribution | |
| 4C330U-P103368 | In distribution | |
| 4C290U-Z10301C | In distribution | |
| 79054C422U-Z131008 | In distribution | |
| 4C215U-Z100108 | In distribution | |
| HC-PS-DAA2-A | In distribution | |
| 4C370U-P003498 | In distribution | |
| 4C210N-P100028 | In distribution | |
| 4C320U-R104248 | In distribution | |
| 4C240U-Z000038 | In distribution | |
| 4C020N-Z504098 | In distribution | |
| 4C100U-Z000048 | In distribution | |
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| 4C290U-P103008 | In distribution | |
| A5061 | In distribution | |
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| 4C19CU-Z104038 | In distribution | |
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| 4C330U-Z102018 | In distribution | |
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| P25104C330U-Z000028 | In distribution | |
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| 4C190U-R122028 | In distribution | |
| HC-PS-DAD2-A | In distribution | |
| 4C330U-R10000C | In distribution | |
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| 4C330U-P118548 | In distribution | |
| 4C055U-Z100008 | In distribution | |
| 4C320U-Z104248 | In distribution | |
| 4C235U-P000008 | In distribution | |
| P25104C331U-P102008 | In distribution | |
| SF31ZKLE | In distribution | |
| 4C211N-Z10000C | In distribution | |
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| P25104C330U-Z100008 | In distribution | |
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| 4C331U-P002388 | In distribution | |
| 4C370U-Z104188 | In distribution | |
| 4C240U-Z10000H | In distribution | |
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| 4C331U-Z10001A | In distribution | |
| 4C230N-Z003028 | In distribution | |
| 4C190U-Z900028 | In distribution | |
| SF41ZKL10 | In distribution | |
| P25104C331U-Z142018 | In distribution | |
| 4C190U-Z103168 | In distribution | |
| 4C19AN-Z000028 | In distribution | |
| 4C320U-R003578 | In distribution | |
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| 4C241U-P105018 | In distribution | |
| 4C190U-R104368 | In distribution | |
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| 4C190U-ZH03038 | In distribution | |
| SF41ZKLE | In distribution | |
| 4C421U-Z103001 | In distribution | |
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| 4C290U-Z10004C | In distribution | |
| 4C330U-P002028 | In distribution | |
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| 4C020N-Z400008 | In distribution | |
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| 4C19CU-P100028 | In distribution | |
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| 4C19DN-Z10420C | In distribution | |
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| GPCS-2Z-DIM | In distribution | |
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| 5C430U-Z30400049 | In distribution | |
| 4C19CN-Z100188 | In distribution | |
| 4C360N-P002008 | In distribution | |
| P25104C331U-Z10501C | In distribution | |
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| 4C19JU-Z10003A | In distribution | |
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| SF31ZKAL10 | In distribution | |
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| 4C080N-R100128 | In distribution | |
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| 4C215U-P104088 | In distribution | |
| 4C331U-Z103001 | In distribution | |
| 4C370U-P100268 | In distribution | |
| 4C331U-Z105018 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.