Delivery Set 16C w/ AA 183cm Line

GUDID 20634624561148

QUEST MEDICAL INC

Cardioplegia solution administration kit

• Primary Device ID: 20634624561148
• NIH Device Record Key: fcc1ecc2-c918-4a30-8edf-299c686d06ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delivery Set 16C w/ AA 183cm Line
• Version Model Number: 5161102-AS
• Company DUNS: 041810693
• Company Name: QUEST MEDICAL INC
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634624561144 [Primary]
GS1	20634624561148 [Package]; Contains: 00634624561144; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173716

FDA Product Code

• DTR: Heat-Exchanger, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-04
• Device Publish Date: 2019-09-26

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