Axess Scavenging Circuit, In-Line 53005

GUDID 00813830026788

ACCUTRON, INC.

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• Primary Device ID: 00813830026788
• NIH Device Record Key: a61113f4-f52f-4526-9252-b252cd1ee027
• Commercial Distribution Discontinuation: 2199-12-14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axess Scavenging Circuit, In-Line
• Version Model Number: 53005
• Catalog Number: 53005
• Company DUNS: 088302096
• Company Name: ACCUTRON, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	00813830026788 [Primary]
GS1	00813830027914 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033503

FDA Product Code

• CBN: Apparatus, Gas-Scavenging

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-14

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