Exoflex 53in. T-Extension Set

GUDID 00634624957794

QUEST MEDICAL INC

Intravenous administration tubing extension set

• Primary Device ID: 00634624957794
• NIH Device Record Key: 260a4bf2-79e2-4898-a18f-0c03aa2c80e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exoflex 53in. T-Extension Set
• Version Model Number: 95779
• 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	00634624957794 [Primary]
GS1	20634624957798 [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: 2019-03-20
• Device Publish Date: 2019-03-12

On-Brand Devices [Exoflex 53in. T-Extension Set ]

• 20634624957897: 95789
• 00634624957794: 95779