22G Open-System Ally Blood Collection Device

GUDID 00850042365014

Avia Vascular, LLC

Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive Blood collection set, noninvasive

• Primary Device ID: 00850042365014
• NIH Device Record Key: 52655fc5-2987-41d9-bf75-0b640ee7802d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 22G Open-System Ally Blood Collection Device
• Version Model Number: AV110000
• Company DUNS: 106772781
• Company Name: Avia Vascular, LLC
• 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: false
• 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

Customer Support Contacts

• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com
• Phone: 8017469453
• Email: mpell@avia-vascular.com

Device Dimensions

• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch
• Outer Diameter: 0.0214 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042365014 [Primary]
GS1	10850042365011 [Package]; Package: Inner Pack [8 Units]; In Commercial Distribution
GS1	20850042365018 [Package]; Contains: 10850042365011; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220258

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

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: 2022-11-01
• Device Publish Date: 2022-10-24

Devices Manufactured by Avia Vascular, LLC

• 00850042365007 - 20G Open-System Ally Blood Collection Device: 2022-11-01
• 00850042365014 - 22G Open-System Ally Blood Collection Device: 2022-11-01
• 00850042365014 - 22G Open-System Ally Blood Collection Device: 2022-11-01