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

GUDID 00813830028379

ACCUTRON, INC.

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• Primary Device ID: 00813830028379
• NIH Device Record Key: 049725de-2b58-4796-bb50-1c26a0a6267b
• Commercial Distribution Discontinuation: 2099-04-09
• 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: false
• 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	00813830028379 [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: 2019-04-17
• Device Publish Date: 2019-04-09

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

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