FRU, Vacuum Gauge, Scanvenging Controllers 28250-FRU

GUDID 00813830025279

ACCUTRON, INC.

Oxygen/air/nitrous oxide breathing gas mixer

• 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

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