Q2 Low Pressure Power Injection Extension Set 95714

GUDID 20634624957149

7 inch IV extension set

QUEST MEDICAL INC

Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 20634624957149
• NIH Device Record Key: f390bfbe-2ad5-456d-98d9-5ea9a0d5ce2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q2 Low Pressure Power Injection Extension Set
• Version Model Number: 95714
• Catalog Number: 95714
• 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

Customer Support Contacts

• Phone: 1-800-627-0226
• Email: custserv@questmedical.com
• Phone: 1-800-627-0226
• Email: custserv@questmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634624957145 [Primary]
GS1	20634624957149 [Package]; Contains: 00634624957145; Package: Shipper [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162804

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2017-03-27

On-Brand Devices [Q2 Low Pressure Power Injection Extension Set]

• 20634624959068: Q2 Low Pressure Power Injection Extension Set
• 20634624957149: 7 inch IV extension set