Sarns™ Temperature Probe Module 15745

GUDID 00886799000151

Temperature Probe Module For TCM II System

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system heating/cooling unit 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

• 50699753531210 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531227 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531234 - Cardiovascular Procedure Kit: 2024-04-19
• 50699753531180 - Cardiovascular Procedure Kit: 2024-04-18
• 00699753531192 - Cardiovascular Procedure Kit: 2024-04-18
• 00699753531208 - Cardiovascular Procedure Kit: 2024-04-18
• 50699753531104 - Cardiovascular Procedure Kit: 2024-04-15
• 50699753531111 - Cardiovascular Procedure Kit: 2024-04-15