Sarns™ Temperature Probe Module 15745
GUDID 00886799000151
Temperature Probe Module For TCM II System
Terumo Cardiovascular Systems Corporation
Cardiopulmonary bypass system heating/cooling unit| Primary Device ID | 00886799000151 |
| NIH Device Record Key | f6409730-0d0d-4cda-8329-c5aeb85c41ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sarns™ Temperature Probe Module |
| Version Model Number | 15745 |
| Catalog Number | 15745 |
| Company DUNS | 177655466 |
| Company Name | Terumo Cardiovascular Systems Corporation |
| 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 | true |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886799000151 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K883603
FDA Product Code
| DWC | Controller, Temperature, Cardiopulmonary Bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2015-09-24 |
Devices Manufactured by Terumo Cardiovascular Systems Corporation
Trademark Results [Sarns]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SARNS 86271501 not registered Dead/Abandoned |
Terumo Cardiovascular Systems Corporation 2014-05-05 |
 SARNS 73676567 1480452 Dead/Cancelled |
AMERICAN ANCHOR, INC. 1987-07-30 |
 SARNS 72305072 0880541 Live/Registered |
SARNS, INC. 1968-08-13 |
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