Main Module, Digital FlushMount 27192-FRU

GUDID 00813830027730

Main Module, Digital FlushMount

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830027730
• NIH Device Record Key: 03a6cbfb-ab6e-49a5-ac32-7a9ecd2c1bbd
• Commercial Distribution Discontinuation: 2199-08-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Main Module, Digital FlushMount
• Version Model Number: 27192-FRU
• Catalog Number: 27192-FRU
• 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	00813830027730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052335

FDA Product Code

• BSZ: Gas-Machine, Anesthesia

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: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [Main Module, Digital FlushMount]

• 00813830027730: Main Module, Digital FlushMount
• 00810085200086: 27192