FRU, Vacuum Gauge, Scanvenging Controllers 28250-FRU

GUDID 00813830025279

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer Oxygen/air/nitrous oxide breathing gas mixer Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger Anaesthesia workstation gas scavenger

• Primary Device ID: 00813830025279
• NIH Device Record Key: e99eb266-9397-4bd6-b472-2302b6f1bd85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FRU, Vacuum Gauge, Scanvenging Controllers
• Version Model Number: 28250-FRU
• Catalog Number: 28250-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	00813830025279 [Primary]

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-28

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