| Primary Device ID | 20857915006016 |
| NIH Device Record Key | 5f49f53d-edee-4afb-9a9c-f24ff8efe310 |
| Commercial Distribution Discontinuation | 2017-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Esophageal Cooling Device |
| Version Model Number | ECD02-A |
| Company DUNS | 961627382 |
| Company Name | Attune Medical |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857915006012 [Primary] |
| GS1 | 10857915006019 [Package] Contains: 00857915006012 Package: Shelf Box [4 Units] Discontinued: 2017-12-31 Not in Commercial Distribution |
| GS1 | 20857915006016 [Package] Contains: 10857915006019 Package: Shipping Box [1 Units] Discontinued: 2017-12-31 Not in Commercial Distribution |
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 20857915006016 | The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Cincinnat |
| 20857915006009 | The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Gaymar Me |