| Primary Device ID | 00858526006965 |
| NIH Device Record Key | 5358e196-86fa-4933-87f9-8d78dfaa7f3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NovaChat |
| Version Model Number | 20062-25 |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Length | 7.94 Inch |
| Width | 4.42 Inch |
| Height | 0.18 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858526006965 [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 | 2023-10-19 |
| Device Publish Date | 2023-10-11 |
| 00816486021343 | NovaChat 10.7 TouchGuide 60 location |
| 00816486021336 | NovaChat 10.7 TouchGuide 42 location |
| 00816486021329 | NovaChat 10.7 TouchGuide 25 Location |
| 00816486021312 | NovaChat 10.7 Set of multiple TouchGuides |
| 00816486021305 | NovaChat 10.7 Keyguard 84 location |
| 00816486021299 | NovaChat 10.7 Keyguard 60 location |
| 00816486021282 | NovaChat 10.7 Keyguard 42 location |
| 00816486021275 | NovaChat 10.7 Keyguard 25 location |
| 00816486021268 | NovaChat 10.7 Keyguard 20 location |
| 00816486021251 | NovaChat 10.7 Keyguard 15 location |
| 00816486021244 | NovaChat 10.7 Set of multiple Keyguards |
| 00816486021220 | Nova Chat 10.7 is a speech generating device with a 10 inch screen. |
| 00816486021381 | NovaChat 8.5 is a speech generating device with an 8 inch screen |
| 00858526006996 | NC8.5 Keyguard 84 location |
| 00858526006989 | NC8.5 Keyguard 60 location |
| 00858526006972 | NC8.5 Keyguard 42 location |
| 00858526006965 | NC8.5 Keyguard 25 location |
| 00858526006958 | NC8.5 Keyguard 20 location |
| 00858526006941 | NC8.5 Keyguard 15 location |
| 00816486021497 | NC8.5 TouchGuide 60 Location |
| 00816486021480 | NC8.5 TouchGuide 25 Location |
| 00816486021473 | NC8.5 TouchGuide 42 location |