Scavenging Circuit I, ClearView 43005

GUDID 00813830023893

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830023893
• NIH Device Record Key: c00ddf38-4734-491d-86cb-a7688431e077
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scavenging Circuit I, ClearView
• Version Model Number: 43005
• Catalog Number: 43005
• 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	00813830023893 [Primary]
GS1	00813830027884 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-06
• Device Publish Date: 2016-09-28

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