PEDIATRIC TRAINING LOOP 201-50134

GUDID 07640135140467

Thoratec Switzerland GmbH

Cardiopulmonary bypass system priming set

• Primary Device ID: 07640135140467
• NIH Device Record Key: f0ab31b1-19c7-4e13-a24b-3ab7c80865ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEDIATRIC TRAINING LOOP
• Version Model Number: 201-50134
• Catalog Number: 201-50134
• 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: true
• Serial Number: false
• 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 Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640135140467 [Primary]

FDA Product Code

• KFM: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

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: 2019-02-06
• Device Publish Date: 2014-09-20

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