| Primary Device ID | 62860105513047 |
| NIH Device Record Key | 254ec364-2742-40f5-b4b9-5553b5d05e9f |
| Commercial Distribution Discontinuation | 2020-04-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | AEROECLIPSE* XL Reusable Breath Actuated Nebulizer |
| Version Model Number | 105513 |
| Catalog Number | 10551394050 |
| Company DUNS | 203298203 |
| Company Name | Trudell Medical International |
| Device Count | 50 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 62860105513030 [Unit of Use] |
| GS1 | 62860105513047 [Primary] |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-04-23 |
| Device Publish Date | 2018-06-29 |
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