| Primary Device ID | 10857175006071 |
| NIH Device Record Key | e556ba64-5260-459c-bb5b-3acf437bd993 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Plastic Mouthpieces (100) |
| Version Model Number | Z-5000-2608 |
| Company DUNS | 828416359 |
| Company Name | VECTRACOR INC |
| Device Count | 100 |
| 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 | false |
| Serial Number | true |
| 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 | 00857175006074 [Unit of Use] |
| GS1 | 10857175006071 [Primary] |
| GS1 | 20857175006078 [Package] Package: [6 Units] In Commercial Distribution |
| BYP | Mouthpiece, Breathing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-09-26 |
| 00857175006067 - 3L Calibration Syringe | 2023-06-15 The 3L calibration syringe is a hollow cylindrical tube with a nozzle at one end that connects to a VectraCor pneumotachometer, |
| 00857175006173 - Universal SmartECG | 2023-06-15 The Universal SmartECG is an ECG amplifier that connects to electrodes on a patient and a PC with Windows operating systems via |
| 10857175006071 - Plastic Mouthpieces (100) | 2020-03-23Plastic Mouthpieces box of 100 |
| 10857175006071 - Plastic Mouthpieces (100) | 2020-03-23 Plastic Mouthpieces box of 100 |
| 40857175006096 - Adhesive Solid Gel Electrodes (pack of 100) | 2018-07-06 Resting EKG Tab Electrodes inner pack of 100 |
| 00857175006012 - Vectraplex CMS | 2018-07-06 Vectraplex Central Monitoring System |
| 00857175006029 - VectraplexECG System | 2018-07-06 VectraplexECG System with Cardio Electrical Bio-marker (CEB) |
| 00857175006043 - Universal ECG | 2018-07-06 ECG Amplifier |
| 00857175006050 - Orbit Spirometer | 2018-07-06 Orbit Spirometer |