High-Flow 4-Way Stopcock Extension

GUDID 00634624921122

QUEST MEDICAL INC

Intravenous administration tubing extension set

• Primary Device ID: 00634624921122
• NIH Device Record Key: 02d2432b-d415-460d-85c8-8b710c42d4be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High-Flow 4-Way Stopcock Extension
• Version Model Number: HFSTV03
• 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	00634624921122 [Primary]
GS1	20634624921126 [Package]; 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: 2022-12-14
• Device Publish Date: 2022-12-06

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

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