| Primary Device ID | 10628693098042 |
| NIH Device Record Key | 34437e38-0cad-48c9-926b-fe49fecdf78d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ByFloProducts |
| Version Model Number | BFP50D1 |
| Company DUNS | 208296406 |
| Company Name | Byflo Products Inc. |
| 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628693098045 [Primary] |
| GS1 | 10628693098042 [Package] Contains: 00628693098045 Package: Box [200 Units] In Commercial Distribution |
| OCH | Oximeter, Infrared, Sporting, Aviation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-24 |
| Device Publish Date | 2022-05-16 |
| 00628693098014 | Infrared Forehead Thermometer |
| 10628693098035 | Non-contact Infrared Thermometer |
| 10628693098042 | Pulse Oximeter |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BYFLOPRODUCTS 97416872 not registered Live/Pending |
Ogier, Florimond 2022-05-18 |