| Primary Device ID | 07640142190646 |
| NIH Device Record Key | 51e9e756-a56b-4f0c-a9c0-77ba38451576 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | spirette FA Pro/LAB |
| Version Model Number | 2050-73 |
| Company DUNS | 487451916 |
| Company Name | NDD Medizintechnik AG |
| Device Count | 200 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640142190646 [Unit of Use] |
| GS1 | 07640142190653 [Primary] |
| GS1 | 07640142190660 [Primary] |
| GS1 | 07640142190684 [Primary] |
| BYP | Mouthpiece, Breathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-23 |
| 07640142190677 - spirette m | 2023-07-03 |
| 07640142190479 - Spiro-SP TrueFlow Sensor | 2023-07-03 |
| 07640142190646 - spirette FA Pro/LAB | 2023-07-03 |
| 07640142190646 - spirette FA Pro/LAB | 2023-07-03 |
| 07640142190486 - spirette | 2023-06-30 |
| 07640142190516 - EasyOne FlowTube | 2023-06-30 |
| 07640142190462 - EasyOne FlowTube | 2023-06-30 |
| 07640142190561 - Filter Adapter SP | 2023-06-30 |
| 07640142190578 - Filter Adapter FT | 2023-06-30 |