| Primary Device ID | 10762860055022 |
| NIH Device Record Key | c6dcb51d-ddf1-46fc-9054-357295b96a70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REUSABLE COMFORTSEAL® Silicone Mask Assembly |
| Version Model Number | 105502 |
| Company DUNS | 203298203 |
| Company Name | Trudell Medical International |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com | |
| Phone | 1-519-455-4862 |
| customerservice@trudellmed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00762860055025 [Primary] |
| GS1 | 10762860055022 [Package] Contains: 00762860055025 Package: [10 Units] In Commercial Distribution |
| BYG | Mask, Oxygen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 10762860055046 | REUSABLE COMFORTSEAL® Silicone Mask Assembly – Large For use with the family of AeroEclipse® |
| 10762860055039 | REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® |
| 10762860055022 | REUSABLE COMFORTSEAL® Silicone Mask Assembly – Medium For use with the family of AeroEclipse |