High-Flow 4-Way Stopcock Extension

GUDID 20634624921119

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 20634624921119
• NIH Device Record Key: 8eabe9c0-5f7d-45b5-b322-424d4606f5ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High-Flow 4-Way Stopcock Extension
• Version Model Number: HFSTV02
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634624921115 [Primary]
GS1	20634624921119 [Package]; Contains: 00634624921115; Package: [50 Units]; In Commercial Distribution

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: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [High-Flow 4-Way Stopcock Extension]

• 20634624921249: HFST01
• 20634624921119: HFSTV02
• 00634624921122: HFSTV03