Digital Ultra Pkg, B, Sed. System, w Bag 56100-SSB

GUDID 00813830028393

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830028393
• NIH Device Record Key: 1c6578c1-9727-4f83-a5f7-4d1067f86e43
• Commercial Distribution Discontinuation: 2099-04-12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Digital Ultra Pkg, B, Sed. System, w Bag
• Version Model Number: 56100-SSB
• Catalog Number: 56100-SSB
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813830028393 [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: 2019-04-22
• Device Publish Date: 2019-04-12

On-Brand Devices [Digital Ultra Pkg, B, Sed. System, w Bag]

• 00813830028379: 56100-SSB
• 00813830028393: 56100-SSB