| Primary Device ID | 00850014981020 |
| NIH Device Record Key | 8dcf0aa0-43f1-4084-b59f-1f83792cf802 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MediBio TD-8255 Fingertip Pulse Oximeter |
| Version Model Number | TD-8255 |
| Company DUNS | 012481654 |
| Company Name | MEDIBIO USA LLC |
| 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 | false |
| Serial Number | true |
| 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 | 00850014981020 [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 | 2020-01-31 |
| Device Publish Date | 2020-01-23 |
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| 00850014981006 - MediBio TD-3140 Blood Pressure Monitor | 2020-01-31 |
| 00850014981013 - Medibio TD-4277 Blood Glucose Monitoring System | 2020-01-31 |
| 00850014981020 - MediBio TD-8255 Fingertip Pulse Oximeter | 2020-01-31 |
| 00850014981020 - MediBio TD-8255 Fingertip Pulse Oximeter | 2020-01-31 |
| 00850014981037 - MediBio TD-2555 Weight Scale | 2020-01-31 |