| Primary Device ID | 00373317495211 | 
| NIH Device Record Key | 2a0fb7b1-c3e4-4be6-9577-1d87981ae630 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | BREATHE COMFORT | 
| Version Model Number | OPTICHAMBERS | 
| Company DUNS | 081225162 | 
| Company Name | Slv Pharmaceuticals LLC | 
| 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 | true | 
| Manufacturing Date | false | 
| Expiration Date | true | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00373317495211 [Primary] | 
| 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 | 2022-03-16 | 
| Device Publish Date | 2022-03-08 | 
| 00373317495228 | BREATHE COMFORT OPTICHAMBERS - ADULT | 
| 00373317495211 | BREATHE COMFORT OPTICHAMBERS - MEDIUM CHILD | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  BREATHE COMFORT  98065911  not registered Live/Pending | AKRON GENERICS LLC 2023-06-29 | 
|  BREATHE COMFORT  90820717  not registered Live/Pending | Prathyusha Guduru 2021-07-09 |