| Primary Device ID | 62860105509026 |
| NIH Device Record Key | 98cbf587-7af3-4be1-ab6b-64547782a91d |
| Commercial Distribution Discontinuation | 2020-03-24 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AEROECLIPSE BAN Replacement Mouthpiece Assembly |
| Version Model Number | 105509 |
| Catalog Number | 10550994080 |
| Company DUNS | 203298203 |
| Company Name | Trudell Medical International |
| Device Count | 80 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 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 | 62860105509019 [Unit of Use] |
| GS1 | 62860105509026 [Primary] |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-04-01 |
| Device Publish Date | 2020-03-24 |
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| 10762860055039 - REUSABLE COMFORTSEAL® Silicone Mask Assembly | 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Small For use with the family of AeroEclipse® nebulizers |
| 10762860055046 - REUSABLE COMFORTSEAL® Silicone Mask Assembly | 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Large For use with the family of AeroEclipse® nebulizers |
| 00762860000827 - AEROCHAMBER* MV Holding Chamber | 2023-12-11 AEROCHAMBER* MV Holding Chamber |
| 10762860055572 - MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing | 2021-06-29 MC300® Nebulizer with Corrugated Tubing, Mouthpiece and Universal Tubing |
| 10762860055534 - AeroEclipse® ONE Breath Actuated Nebulizer Disposable | 2020-08-11 AeroEclipse® ONE Breath Actuated Nebulizer Disposable |
| 10762860105024 - AEROBIKA OPEP Manometer | 2020-04-30 AEROBIKA OPEP Manometer |