Ultra DC Oral Surgery Package A 46000OS

GUDID 00813830023084

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830023084
• NIH Device Record Key: cdc3424e-3394-4bb9-8c8f-746865271c44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra DC Oral Surgery Package A
• Version Model Number: 46000OS
• Catalog Number: 46000OS
• 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	00813830023084 [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

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

• 00813830026771: 46000-OS
• 00813830023084: 46000OS