| Primary Device ID | 10852367007133 |
| NIH Device Record Key | 063b2ca5-a63f-4309-94b3-9fdf21588fb9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InspiraChamber Valved Holding Chamber |
| Version Model Number | 1001-10SM |
| Company DUNS | 967174850 |
| Company Name | INSPIRX, 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 | 1-888-471-4990 |
| ronnie.toddywala@inspirxpharma.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852367007136 [Primary] |
| GS1 | 10852367007133 [Package] Contains: 00852367007136 Package: case [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 | 2019-12-19 |
| Device Publish Date | 2019-12-11 |
| 10852367007003 | InspiraChamber Anti-Static Valved Holding Chamber- Hospital Unit |
| 10852367007065 | InspiraChamber Anti-Static Valved Holding Chamber (Teleflex medical) 1001-50 |
| 10852367007058 | InspiraChamber Anti-Static Valved Holding Chamber (Teleflex Medical) 1001-10 |
| 10852367007164 | InspiraChamber with InspiraMask (Small) (Teleflex Medical) 1001-10S |
| 10852367007157 | InspiraChamber with InspiraMask (Medium) (Teleflex Medical) 1001-10M |
| 10852367007133 | InspiraChamber with SootherMask (Medium) (Teleflex Medical) 1001-10SM |
| 10852367007126 | InspiraChamber with InspiraMask (Large) (Teleflex Medical) 1001-10L |
| 10852367007072 | InspiraChamber with SootherMask (Small) (Teleflex Medical) 1001-10SS |