EU Scavenging Circuit I 33010EU

GUDID 00813830021479

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• Primary Device ID: 00813830021479
• NIH Device Record Key: 802ea131-2a9b-446b-b89b-4a2ea7b4fc37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EU Scavenging Circuit I
• Version Model Number: 33010EU
• Catalog Number: 33010EU
• 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	00813830021479 [Primary]
GS1	00813830027860 [Direct Marking]

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: 4
• Public Version Date: 2018-11-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ACCUTRON, INC.

• 00813830028171 - WAGD Chemetron x 1/2" MNPT: 2023-11-28
• 00813830021066 - FRU, Vacuum Connector With Barbs: 2023-10-13
• 00813830022094 - Accutron Vacuum Male Connector: 2023-10-13
• 00813830026856 - FRU, Axess Vacuum Gauge: 2023-10-13
• 00813830026924 - FRU, Valve, Pressure Relief, Digi-Flo: 2023-10-13
• 00813830026979 - FRU, Gauge Newport O2: 2023-10-13
• 00813830027006 - FRU, O2 Hose, 2 Cyl.: 2023-10-13
• 00813830027013 - FRU, N2O Hose, 2 Cyl.: 2023-10-13