16 in. (38 cm) Q2 Checkmate extension set 9548

GUDID 20634624954803

QUEST MEDICAL INC

Intravenous administration tubing extension set

• Primary Device ID: 20634624954803
• NIH Device Record Key: 58711058-603c-4874-a416-5a8722387963
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 16 in. (38 cm) Q2 Checkmate extension set
• Version Model Number: 9548
• Catalog Number: 9548
• 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	00634624954809 [Primary]
GS1	20634624954803 [Package]; Contains: 00634624954809; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162304

FDA Product Code

• FPK: Tubing, Fluid Delivery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-22

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