ProPlege Device Kit PR9

GUDID 00690103189995

Thruport Systems ProPlege Peripheral Retrograde Cardioplegia Device

Edwards Lifesciences LLC

Coronary sinus cannula

• Primary Device ID: 00690103189995
• NIH Device Record Key: 7651993a-5fcf-4394-9095-668ecb4e4df1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProPlege Device Kit
• Version Model Number: PR9
• Catalog Number: PR9
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 * Store sterile packaged device in a cool dry place.
• Special Storage Condition, Specify: Between 0 and 0 * Store sterile packaged device in a cool dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103189995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120780

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

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