Ultra DC Oral Surgery Package A 46000-OS

GUDID 00813830026771

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 Oxygen/air/nitrous oxide breathing gas mixer Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830026771
• NIH Device Record Key: 412f29f6-2080-476b-9451-1fd45868dd17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra DC Oral Surgery Package A
• Version Model Number: 46000-OS
• Catalog Number: 46000-OS
• 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: true
• 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	00813830026771 [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: 2017-03-08

On-Brand Devices [Ultra DC Oral Surgery Package A]

• 00813830026771: 46000-OS
• 00813830023084: 46000OS