20G Open-System Ally Blood Collection Device

GUDID 00850042365007

Avia Vascular, LLC

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• Primary Device ID: 00850042365007
• NIH Device Record Key: 80eb8b2f-f89a-446b-b111-a8d1f8e3e584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 20G Open-System Ally Blood Collection Device
• Version Model Number: AV100000
• 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

Device Dimensions

• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch
• Outer Diameter: 0.0274 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850042365007 [Primary]
GS1	10850042365004 [Package]; Package: Inner Pack [8 Units]; In Commercial Distribution
GS1	20850042365001 [Package]; Contains: 10850042365004; 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
• 00850042365007 - 20G Open-System Ally Blood Collection Device: 2022-11-01
• 00850042365014 - 22G Open-System Ally Blood Collection Device: 2022-11-01