| Primary Device ID | 36704820000053 |
| NIH Device Record Key | 179a347f-d06b-48a8-b13d-330a8fdd604a |
| Commercial Distribution Discontinuation | 2016-09-21 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Florence bed |
| Version Model Number | FL23SE ERGO |
| Catalog Number | FL23SE |
| Company DUNS | 249675476 |
| Company Name | Umano Medical Inc |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Handling Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 16704820000059 [Primary] |
| GS1 | 26704820000056 [Package] Contains: 16704820000059 Package: [1 Units] Discontinued: 2016-09-21 Not in Commercial Distribution |
| GS1 | 36704820000053 [Package] Contains: 16704820000059 Package: [2 Units] Discontinued: 2016-09-21 Not in Commercial Distribution |
| FNL | Bed, Ac-Powered Adjustable Hospital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-11-30 |
| 20670482000054 | AC-powered hospital bed with four built-in electric DC motors and remote controls that is intend |
| 20670482000047 | AC-powered hospital bed with four built-in electric DC motors and remote controls that is intend |
| 36704820000053 | AC-powered hospital bed with four built-in electric DC motors and remote controls that is intend |
| 16704820000042 | AC-powered hospital bed with four built-in electric DC motors and remote controls that is intend |