ClearMate
GUDID 10807141000107
Assy, ClearMate, DISS, US
Thornhill Research Inc
Oxygen/air breathing gas mixer, emergency| Primary Device ID | 10807141000107 |
| NIH Device Record Key | b76f2017-a3e4-492d-aaca-0e80ab620b1c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearMate |
| Version Model Number | 128222 |
| Company DUNS | 205151975 |
| Company Name | Thornhill Research 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10807141000107 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN170044
FDA Product Code
| QFB | Isocapnic Ventilation Device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-09 |
| Device Publish Date | 2020-10-01 |
On-Brand Devices [ClearMate]
| 18071411282223 | ClearMate TM is intended to be used by emergency department medical professionals as an adjunct |
| 10807141000107 | Assy, ClearMate, DISS, US |
Trademark Results [ClearMate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CLEARMATE 97496132 not registered Live/Pending |
Golbraich, Maxim 2022-07-10 |
CLEARMATE 97496132 not registered Live/Pending |
Shoshan, Moti 2022-07-10 |
CLEARMATE 97496132 not registered Live/Pending |
Kohen, Amiram 2022-07-10 |
 CLEARMATE 75744979 not registered Dead/Abandoned |
Gillette Company, The 1999-07-07 |
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