Exoflex 10.5in. IVExtension Set

GUDID 00634624957817

QUEST MEDICAL INC

Intravenous administration tubing extension set

• Primary Device ID: 00634624957817
• NIH Device Record Key: a94487ee-68f9-472a-9339-c3c2834363b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exoflex 10.5in. IVExtension Set
• Version Model Number: 95781
• 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	00634624957817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162304

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: 2019-12-17
• Device Publish Date: 2019-12-09

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• 20634624921102 - High-Flow 4-Way Stopcock: 2022-12-14