Precision Delivery IV Extension Set, Amber

GUDID 20634624921010

QUEST MEDICAL INC

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• Primary Device ID: 20634624921010
• NIH Device Record Key: bfa1853e-688a-4462-b3cc-c529e2d6891a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Delivery IV Extension Set, Amber
• Version Model Number: PDTV05DFA
• 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	00634624921016 [Primary]
GS1	20634624921010 [Package]; Contains: 00634624921016; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202672

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2021-07-02
• Device Publish Date: 2021-06-24

On-Brand Devices [Precision Delivery IV Extension Set, Amber]

• 20634624922048: PDV60FA
• 20634624921072: PDV06A
• 20634624921065: PDV60A
• 20634624921034: PDTV05A
• 20634624921027: PDTV05FA
• 20634624921010: PDTV05DFA