| Primary Device ID | 00857175006050 |
| NIH Device Record Key | 9663ee22-33b9-42a3-81c7-20e92c82c9e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Orbit Spirometer |
| Version Model Number | Z-7000-0101 |
| Catalog Number | Z-7000-0101 |
| Company DUNS | 828416359 |
| Company Name | VECTRACOR INC |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | 00857175006050 [Primary] |
| BZG | Spirometer, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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| 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 | 2018-07-06Orbit Spirometer |
| 00857175006050 - Orbit Spirometer | 2018-07-06 Orbit Spirometer |