Surgical Free Flow Vacuum Regulator

GUDID 00628101609221

Vacuum Regulator, Surgical Free Flow, 760mmHg Analog

OHIO MEDICAL, LLC

Vacuum suction regulator/regulation set, general-purpose

• Primary Device ID: 00628101609221
• NIH Device Record Key: f1f3a930-4229-41ac-a6df-b85bde0b4cfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Free Flow Vacuum Regulator
• Version Model Number: SCHA
• Company DUNS: 005192885
• Company Name: OHIO MEDICAL, LLC
• 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: false
• 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

Customer Support Contacts

• Phone: 18478550500
• Email: customer.service@ohiomedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628101609221 [Primary]
GS1	08688250002238 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861261

FDA Product Code

• GCX: Apparatus, Suction, Operating-Room, Wall Vacuum Powered

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: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [Surgical Free Flow Vacuum Regulator]

• 08688250002252: Vacuum Regulator, Surgical Free Flow, 200mmHg Analog
• 08688250002238: Vacuum Regulator, Surgical Free Flow, 760mmHg Analog
• 00628101609245: Vacuum Regulator, Surgical Free Flow, 200mmHg Analog
• 00628101609221: Vacuum Regulator, Surgical Free Flow, 760mmHg Analog