Precision Delivery IV Extension Set

GUDID 20634624621040

QUEST MEDICAL INC

Intravenous administration tubing extension set

• Primary Device ID: 20634624621040
• NIH Device Record Key: cfb0a261-8688-4bf7-8d9f-4747c29e2309
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precision Delivery IV Extension Set
• Version Model Number: PDM60F
• 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	00634624621046 [Primary]
GS1	20634624621040 [Package]; Contains: 00634624621046; 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 IV Extension Set]

• 20634624621101: PDV60F
• 20634624621095: PDV60
• 20634624621088: PDV06F
• 20634624621071: PDV06
• 20634624621064: PDMV60F
• 20634624621057: PDMV60
• 20634624621040: PDM60F
• 20634624621033: PDM60
• 20634624621026: PD60F
• 20634624621019: PD60
• 20634624911066: PD06F