| Primary Device ID | 00860011790310 | 
| NIH Device Record Key | d92ec7b4-2cb6-47ba-9c61-733c1baee8b8 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Sodium Chloride for Inhalation Solution 0.9% | 
| Version Model Number | 3 mL | 
| Catalog Number | REF 62135-832-84 | 
| Company DUNS | 079394054 | 
| Company Name | Chartwell Rx, LLC | 
| Device Count | 30 | 
| 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 | true | 
| Lot Batch | true | 
| Serial Number | true | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | |
| Phone | 1-845-232-1683 | 
| cs@chartwellpharma.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00860011790303 [Primary] | 
| GS1 | 00860011790310 [Unit of Use] | 
| GS1 | 00860011790327 [Package] Contains: 00860011790303 Package: [6 Units] In Commercial Distribution | 
| CAF | Nebulizer (Direct Patient Interface) | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-04-04 | 
| Device Publish Date | 2024-03-27 |