| Primary Device ID | 10627987360117 |
| NIH Device Record Key | 7f700a65-1628-42bc-b3ce-e36753334528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrogel Adhesive Strap |
| Version Model Number | FP120-FOT01-003 |
| Company DUNS | 204195374 |
| Company Name | 1929803 Ontario Corp |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627987360110 [Primary] |
| GS1 | 10627987360117 [Package] Contains: 00627987360110 Package: Bag [10 Units] In Commercial Distribution |
| DPW | Flowmeter, Blood, Cardiovascular |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-17 |
| 10627987360131 - Reprocess FloPatch | 2023-05-16 |
| 10627987360148 - Dual Adhesive Strap | 2023-03-13 |
| 10627987360117 - Hydrogel Adhesive Strap | 2022-06-27 |
| 10627987360117 - Hydrogel Adhesive Strap | 2022-06-27 |
| 00627987360127 - Acrylate Adhesive Strap | 2022-06-27 |
| 00627987360103 - FloPatch | 2020-10-29 |
| 20627987360114 - FloPatch | 2020-09-30 |