| Primary Device ID | 00627987231168 |
| NIH Device Record Key | 82f84898-facc-48c1-9a5c-ce9eabf62bb3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sheeted HealX |
| Version Model Number | 1 |
| Company DUNS | 202686960 |
| Company Name | Swift Medical 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| 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 | 00627987231168 [Primary] |
| FTY | Tape, Measuring, Rulers And Calipers |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-18 |
| Device Publish Date | 2024-09-10 |
| 00627987231168 - Sheeted HealX | 2024-09-18 |
| 00627987231168 - Sheeted HealX | 2024-09-18 |
| 00627987231151 - Ray 1 | 2022-04-26 Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of |
| 00627987231144 - Swift Vision | 2021-03-23 |
| 00627987231120 - HealX | 2020-03-23 |
| 00627987231090 - Swift Skin and Wound | 2019-10-14 |
| 00627987231106 - PointClickCare Skin and Wound | 2019-10-14 |
| 00627987231113 - Healogics Photo+ | 2019-10-14 |
| 00627987231137 - Medline NE1® WMS | 2019-10-14 |