| Primary Device ID | B20083012 |
| NIH Device Record Key | 6a97bbea-7950-4612-bacf-2fab44745881 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shape Vital Sign System |
| Version Model Number | 0008-3012 |
| Company DUNS | 021315587 |
| Company Name | SHAPE MEDICAL SYSTEMS, 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B20083012 [Primary] |
| BTY | Calculator, Predicted Values, Pulmonary Function |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-10 |
| Device Publish Date | 2019-05-02 |
| B2009012 - Shape II System Refurbished | 2022-04-22 Full Shape II system with paramagnetic analyzer |
| B20044012 - Disposable Patient Interface with filter | 2019-05-10 Disposable patient interface with filter 0004-4012 |
| B20083012 - Shape Vital Sign System | 2019-05-10Full Shape system with paramagnetic analyzer |
| B20083012 - Shape Vital Sign System | 2019-05-10 Full Shape system with paramagnetic analyzer |
| B200HF012 - Shape | 2019-05-10 Paramagnetic Shape analyzer Product 0012 |
| B20040011 - Shape | 2018-07-06 Shape DPI |
| B20044001 - Shape-HF | 2018-07-06 Disposable Patient Interface is part of the Shape-HF testing system |
| B20089001 - Shape-HF | 2018-07-06 Shape-HF system |
| B200HF001 - Shape-HF | 2018-07-06 Shape-HF analyzer |