| Primary Device ID | 00146191200505 |
| NIH Device Record Key | d71c1e1c-3dfb-4f65-9874-83f511527d43 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Andnesfit Health |
| Version Model Number | ADF-B05 |
| Company DUNS | 664101036 |
| Company Name | ANDESFIT LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00146191200505 [Primary] |
| DQA | Oximeter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-19 |
| Device Publish Date | 2019-12-11 |
| 00146191288527 | ITO Wireless Body Fat Scale |
| 00146191202776 | Blood Glucose Test Strip |
| 00146191202707 | Blood Glucose Monitoring System |
| 00146191200505 | Wireless pulse oximeter |
| 00146191203407 | Wireless Infrared Ear/Forehead Thermometer |
| 04897100310018 | Wireless Pulse Oximeter |
| 04897100310162 | Wireless Spirometer |
| 04897100310070 | Blood Glucose Monitoring System |
| 04897100310025 | Wireless Pulse Oximeter |
| 04897100310155 | ITO Wireless Body Fat Scale |
| 04897100310131 | Wireless Non-Contact Infrared Body/Surface Thermometer |
| 04897100310117 | Wireless Infrared Ear/Forehead Thermometer |
| 04897100310056 | Wireless Arm Type Blood Pressure Monitor |