| Primary Device ID | 00816486021633 |
| NIH Device Record Key | e947040c-7bad-4d5d-95b4-3f27511bf619 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unity Discover App |
| Version Model Number | Unity |
| Company DUNS | 080143399 |
| Company Name | PRENTKE ROMICH COMPANY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816486021633 [Primary] |
| ILQ | System, Communication, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-13 |
| Device Publish Date | 2025-08-05 |
| 00816486021633 - Unity Discover App | 2025-08-13Unity Discover App |
| 00816486021633 - Unity Discover App | 2025-08-13 Unity Discover App |
| 00816486021541 - PRC-Saltillo | 2025-02-14 Via Nano 6.1 is a speech generating device with an 6" screen. |
| 00816486021015 - Saltillo | 2023-11-16 TouchChat HD w/ WordPower App |
| 00816486021022 - Saltillo | 2023-11-16 Classic TouchChat App |
| 00816486021039 - Saltillo | 2023-11-16 Classic TouchChat w/ WordPower App |
| 00816486021053 - Saltillo | 2023-11-16 TouchChat HD App |
| 00816486021060 - PRC | 2023-11-16 Quasselkiste App |
| 00816486021077 - PRC | 2023-11-16 LAMP Words For Life (UK) App |