| Primary Device ID | 00850644007008 |
| NIH Device Record Key | a191ed13-a191-47cd-b13b-98ca3220a2cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gold Edition Carbon Dioxide Analyzer |
| Version Model Number | 17515 |
| Catalog Number | 17515 |
| Company DUNS | 077967081 |
| Company Name | Vacumed |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Phone | +1(800)235-3333 |
| info@vacumed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850644007008 [Primary] |
| CCK | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE |
| 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 | 2016-09-14 |
| 00850644007169 - Disposable Mouthpiece 19mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007176 - Disposable Mouthpiece 19mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007206 - Disposable Mouthpiece 22mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007213 - Disposable Mouthpiece 22mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007220 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007237 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007244 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |
| 00850644007251 - Disposable Mouthpiece 35mm OD | 2020-03-23 cardboard mouthpiece |