| Primary Device ID | B279298040F100 |
| NIH Device Record Key | 61ae8f35-6974-4b3f-a469-0fd8905a45e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FloSense II |
| Version Model Number | KK |
| Catalog Number | 29-8040F-100 |
| Company DUNS | 037690120 |
| Company Name | S D I DIAGNOSTICS INC |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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 |
|---|---|
| HIBCC | 298040F1002 [Unit of Use] |
| HIBCC | B279298040F100 [Primary] |
| HIBCC | B279298040F1002 [Unit of Use] |
| BZG | Spirometer, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-07-26 |
| B279S298040250 | FloSense II |
| B279S298040100 | FloSense II |
| B279S298040200 | FloSense II |
| B279DP311250 | FloSense II |
| B279DP311100 | FloSense II |
| B279DP311200 | FloSense II |
| B279DP301250 | FloSense II Sensor |
| B279DP301100 | FloSense II Sensor |
| DP301200 | FloSense II Sensor |
| B279DP300250 | FloSense II Sensor |
| B279DP300100 | FloSense II Sensor |
| B279DP300200 | FloSense II Sensor |
| B279298040K250 | FloSense II |
| B279298040K100 | FloSense II |
| B279298040200 | FloSense II |
| B279298040F250 | FloSense II |
| B279298040F100 | FloSense II |
| B279298040F050 | FloSense II |