EM-TEC PEDIATRIC FLOW PROBE FOR 2ND GEN CENTRIMAG 201-30107

GUDID 07640135140115

Thoratec Switzerland GmbH

Extracorporeal fluid flow probe

• Primary Device ID: 07640135140115
• NIH Device Record Key: 618e5f31-e492-4d11-81b6-dc2997283a5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM-TEC PEDIATRIC FLOW PROBE FOR 2ND GEN CENTRIMAG
• Version Model Number: 201-30107
• Catalog Number: 201-30107
• Company DUNS: 486066918
• Company Name: Thoratec Switzerland GmbH
• 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

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70.2 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640135140115 [Primary]

FDA Product Code

• DWA: Control, Pump Speed, 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: 2019-01-31
• Device Publish Date: 2014-09-20

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