MPS® Mini-Prime Delivery Set

GUDID 00634624701113

MPS® Mini-Prime Delivery Set with Arrest and Additive Cassettes

QUEST MEDICAL INC

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• Primary Device ID: 00634624701113
• NIH Device Record Key: 043efd1f-b4f2-4249-86ea-6091f0ed3276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MPS® Mini-Prime Delivery Set
• Version Model Number: 7001101
• 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	00634624701113 [Primary]
GS1	20634624701117 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953838

FDA Product Code

• DTR: Heat-Exchanger, 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: 2015-10-06

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