| Primary Device ID | 00840682138161 |
| NIH Device Record Key | 87eade2c-0071-4c3f-8fe9-99fdbd9dae4f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | D-LITE PATIENT SPIROMETRY SET 2104297-001 |
| Company DUNS | 401966697 |
| Company Name | GE Healthcare Finland Oy |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682138161 [Primary] |
| GS1 | 00840682138246 [Package] Package: [20 Units] In Commercial Distribution |
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2019-06-19 |
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