Precision Delivery Trifurcated IV Extension Set

GUDID 20634624621125

QUEST MEDICAL INC

Intravenous administration tubing extension set

• Primary Device ID: 20634624621125
• NIH Device Record Key: 237e38b2-1a0a-49b7-8423-7318e6328822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Delivery Trifurcated IV Extension Set
• Version Model Number: PDT05DF
• 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	00634624621121 [Primary]
GS1	20634624621125 [Package]; Contains: 00634624621121; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202672

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: 2021-02-15
• Device Publish Date: 2021-02-05

On-Brand Devices [Precision Delivery Trifurcated IV Extension Set]

• 20634624621163: PDTV05DF
• 20634624621156: PDTV05F
• 20634624621149: PDTV05
• 20634624621132: PDT05F
• 20634624621125: PDT05DF
• 20634624621118: PDT05