Ultra PC% Oral Surgery Package H 36800-OS

GUDID 00810085200130

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00810085200130
• NIH Device Record Key: b42e2e75-2043-420b-9fbd-30615b106ce6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra PC% Oral Surgery Package H
• Version Model Number: 36800-OS
• Catalog Number: 36800-OS
• 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	00810085200130 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-22
• Device Publish Date: 2025-05-14

Devices Manufactured by ACCUTRON, INC.

• 00810085200130 - Ultra PC% Oral Surgery Package H: 2025-05-22
• 00810085200130 - Ultra PC% Oral Surgery Package H: 2025-05-22
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