| 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 |