| Primary Device ID | 00812293013434 | 
| NIH Device Record Key | f7fb7ca4-ec7a-4e24-93bf-03923ce6f9ec | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Fall Guardian | 
| Version Model Number | FG1FM7-SYS | 
| Company DUNS | 012082397 | 
| Company Name | Smart Caregiver Corporation | 
| 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 | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00812293013434 [Primary] | 
| KMI | Monitor, Bed Patient | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-07-27 | 
| Device Publish Date | 2022-07-19 | 
| 00812293015230 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293013397 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293013328 | Fall Guardian Basic Monitor | 
| 00812293015445 | Fall Guardian Pager case | 
| 00812293015346 | Fall Guardian Economy Monitor with chair pad case | 
| 00812293015339 | Fall Guardian Economy Monitor with bed pad case | 
| 00812293015322 | Fall Guardian Economy Monitor with bed pad case | 
| 00812293015315 | FallGuard Economy Monitor with chair pad case | 
| 00812293015308 | Fall Guardian Economy Monitor with bed pad case | 
| 00812293015292 | Fall Guardian Economy Monitor with bed pad case | 
| 00812293015285 | Fall Guardian Economy Monitor with chair pad case | 
| 00812293015278 | Fall Guardian Economy Monitor with bed pad case | 
| 00812293015261 | Fall Guardian Economy Monitor with bed pad case | 
| 00812293015254 | Fall Guardian Basic Monitor and chair sensor pad case | 
| 00812293015247 | Fall Guardian Basic Monitor and bed sensor pad case | 
| 00812293015223 | Fall Guardian Basic Monitor and chair sensor pad case | 
| 00812293015216 | Fall Guardian Basic Monitor and bed sensor pad case | 
| 00812293015209 | Fall Guardian Basic Monitor and bed sensor pad case | 
| 00812293015193 | Fall Guardian Basic Monitor and chair sensor pad case | 
| 00812293015186 | Fall Guardian Basic Monitor and bed sensor pad case | 
| 00812293015179 | Fall Guardian Basic Monitor and bed sensor pad case | 
| 00812293013687 | Fall Guardian Pager | 
| 00812293013564 | Fall Guardian Wireless Economy Monitor | 
| 00812293013557 | FallGuard Economy Monitor with floor mat | 
| 00812293013540 | Fall Guardian Economy Monitor with floor mat | 
| 00812293013533 | Fall Guardian Economy Monitor with chair pad | 
| 00812293013526 | Fall Guardian Economy Monitor with bed pad | 
| 00812293013519 | Fall Guardian Economy Monitor with bed pad | 
| 00812293013502 | FallGuard Economy Monitor with chair pad | 
| 00812293013496 | Fall Guardian Economy Monitor with bed pad | 
| 00812293013489 | Fall Guardian Economy Monitor with bed pad | 
| 00812293013472 | Fall Guardian Economy Monitor with chair pad | 
| 00812293013465 | Fall Guardian Economy Monitor with bed pad | 
| 00812293013458 | Fall Guardian Economy Monitor with bed pad | 
| 00812293013441 | Fall Guardian Economy Monitor | 
| 00812293013434 | Fall Guardian Basic Monitor and floor mat | 
| 00812293013427 | Fall Guardian Basic Monitor and floor mat | 
| 00812293013410 | Fall Guardian Basic Monitor and chair sensor pad | 
| 00812293013403 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293013380 | Fall Guardian Basic Monitor and chair sensor pad | 
| 00812293013373 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293013366 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293013359 | Fall Guardian Basic Monitor and chair sensor pad | 
| 00812293013342 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293013335 | Fall Guardian Basic Monitor and bed sensor pad | 
| 00812293015469 | Fall Guardian Two Call Button Paging System cast | 
| 00812293015452 | Fall Guardian Motion Sensor and Pager case | 
| 00812293015438 | Fall Guardian Wireless Economy Monitor with chair pad and pager case | 
| 00812293015421 | Fall Guardian Wireless Economy Monitor with bed pad and pager case | 
| 00812293015414 | Fall Guardian Wireless Economy Monitor with pad and pager case | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  FALL GUARDIAN  88250672  not registered Live/Pending | 1963 2019-01-04 |