| Primary Device ID | 30327437043013 |
| NIH Device Record Key | 6472a2d0-2fdb-4ce0-95fe-f5b8237c45b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Inspirachamber with Inspiramask (Large) |
| Version Model Number | IPX1043 |
| Company DUNS | 089153071 |
| Company Name | LUPIN PHARMACEUTICALS, INC. |
| 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 | true |
| 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 | 1-800-399-2561 |
| info@askarm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00327437043012 [Primary] |
| GS1 | 30327437043013 [Package] Contains: 00327437043012 Package: Shipper [10 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 | 2019-09-09 |
| Device Publish Date | 2019-08-30 |
| 00327437024011 - InspiraChamber Anti-static Valved Holding Chamber | 2019-09-09 InspiraChamber Anti-static Valved Holding Chamber (Retail Unit) |
| 30327437025019 - Inspirachamber with SootherMask (small) and InspiraMask (small) | 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (small) and InspiraMask (small) (Retail Unit) |
| 30327437026016 - Inspirachamber with SootherMask (medium) and InspiraMask (medium) | 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with SootherMask (medium) and InspiraMask (medium) (Retail Unit) |
| 30327437043013 - Inspirachamber with Inspiramask (Large) | 2019-09-09Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit) |
| 30327437043013 - Inspirachamber with Inspiramask (Large) | 2019-09-09 Inspirachamber Anti-static Valved Holding Chamber with InspiraMask (Large) (Retail Unit) |