| Primary Device ID | 00383730000695 |
| NIH Device Record Key | fc6d3811-c7fc-4a25-a2cd-edd66d34c83f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ProChamber Assembly |
| Version Model Number | 00 |
| Catalog Number | 1117489 |
| Company DUNS | 220018415 |
| Company Name | RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00383730000695 [Primary] |
| BWF | SPIROMETER, THERAPEUTIC (INCENTIVE) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-12 |
| Device Publish Date | 2016-08-24 |
| 00383730000718 | PROCHAMBER VHC - 50PK |
| 00383730000701 | PROCHAMBER WMEDIUM SILICONE MASK 50-pack |
| 00383730000695 | PROCHAMBER WITH SMALL SILICONE MASK 50-pack |
| 00383730000688 | PROCHAMBER WITH LARGE SILICONE MASK 50-pack |
| 00383730000671 | PROCHAMBER RETAIL - 10PK |
| 00383730000664 | PROCHAMBER SPAIN - 10PK |
| 00383730000657 | ProChamber Assembly |