Kit, PC To Remote Outlet 27542

GUDID 00813830023749

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer Oxygen/air/nitrous oxide breathing gas mixer Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Inhalational analgesia unit Oxygen/air/nitrous oxide breathing gas mixer Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830023749
• NIH Device Record Key: c1c9e9fe-a406-41e7-928d-d5925ceedca0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kit, PC To Remote Outlet
• Version Model Number: 27542
• Catalog Number: 27542
• 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	00813830023749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K970163

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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