| Primary Device ID | 04048675040545 |
| NIH Device Record Key | 6767ca60-e8d9-4aca-99ca-92f1d1ecb7d3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Headgear f.NovaStar TS |
| Version Model Number | MP01583 |
| Company DUNS | 315578914 |
| Company Name | Drägerwerk AG & Co. KGaA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048675040545 [Primary] |
| BTK | Strap, Head, Gas Mask |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-17 |
| 04048675034643 - Connector M34X1.5, 9/16 | 2026-02-12 |
| 04048675034735 - Adapter 9/16" to 6mm | 2026-02-12 |
| 04048675013532 - CORRUGATED BELLOWS K | 2026-02-03 |
| 04048675558736 - Filter SafeStar 55 Plus | 2026-01-23 |
| 04048675665762 - Filter SafeStar 90 Plus | 2026-01-23 |
| 04048675665786 - Filter SafeStar 60A Plus | 2026-01-23 |
| 04048675665823 - Filter/HME TwinStar HEPA Plus | 2026-01-23 |
| 04048675253426 - Mask NovaStarTS,NIV,w/SE,L | 2026-01-16 |