| Primary Device ID | 10762860001135 |
| NIH Device Record Key | eaf758b8-5d6c-41a0-8eaa-8ca136e48fc2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESPICHAMBER* VHC with Mouthpiece |
| Version Model Number | 101533 |
| 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 | 00762860001138 [Primary] |
| GS1 | 10762860001135 [Package] Contains: 00762860001138 Package: [100 Units] In Commercial Distribution |
| NVP | Holding Chambers, 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 | 2024-03-19 |
| Device Publish Date | 2024-03-11 |
| 10762860001135 - RESPICHAMBER* VHC with Mouthpiece | 2024-03-19RESPICHAMBER™ VHC with Mouthpiece |
| 10762860001135 - RESPICHAMBER* VHC with Mouthpiece | 2024-03-19 RESPICHAMBER™ VHC with Mouthpiece |
| 10762860055022 - REUSABLE COMFORTSEAL® Silicone Mask Assembly | 2024-03-19 REUSABLE COMFORTSEAL® Silicone Mask Assembly – Medium For use with the family of AeroEclipse® nebulizers |
| 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 |