| Primary Device ID | 07640142190486 |
| NIH Device Record Key | c5be55c4-7ed8-4607-b3a0-3bd889a17b08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | spirette |
| Version Model Number | 2050-10 |
| Company DUNS | 487451916 |
| Company Name | NDD Medizintechnik AG |
| Device Count | 500 |
| 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 | 07640142190233 [Primary] |
| GS1 | 07640142190240 [Primary] |
| GS1 | 07640142190400 [Primary] |
| GS1 | 07640142190486 [Unit of Use] |
| 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 | 2023-06-30 |
| Device Publish Date | 2023-06-22 |
| 07640142190677 - spirette m | 2023-07-03 |
| 07640142190479 - Spiro-SP TrueFlow Sensor | 2023-07-03 |
| 07640142190646 - spirette FA Pro/LAB | 2023-07-03 |
| 07640142190486 - spirette | 2023-06-30 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPIRETTE 86280532 4715056 Live/Registered |
Minitub GmbH 2014-05-14 |
![]() SPIRETTE 77754847 3734176 Live/Registered |
ndd Medical Technologies, Inc. 2009-06-08 |
![]() SPIRETTE 74270706 not registered Dead/Abandoned |
LABORATOIRE C C D 1992-04-30 |