Q2 Blood Administration Set

GUDID 20634624921201

QUEST MEDICAL INC

Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange Blood transfusion set, non-exchange

• Primary Device ID: 20634624921201
• NIH Device Record Key: 0fabd67f-e205-4693-84bd-202c5e9f7ab1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Q2 Blood Administration Set
• Version Model Number: YV115
• 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	00634624921207 [Primary]
GS1	20634624921201 [Package]; Contains: 00634624921207; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213846

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 [Q2 Blood Administration Set]

• 20634624921218: YV130
• 20634624921201: YV115