Tote-L-Vac

GUDID 08688250002405

Portable Suction Pump

OHIO MEDICAL, LLC

Emergency airway clearance suction system, electric

• Primary Device ID: 08688250002405
• NIH Device Record Key: b6fd0d2f-5f2e-4ae2-b3bc-e7401816061f
• Commercial Distribution Discontinuation: 2020-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tote-L-Vac
• Version Model Number: Tote-L-Vac
• 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	08688250002405 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932051

FDA Product Code

• BTA: Pump, Portable, Aspiration (Manual Or Powered)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-04-30
• Device Publish Date: 2016-09-24

On-Brand Devices [Tote-L-Vac]

• 08688250002405: Portable Suction Pump
• 00628101609320: Portable Suction Pump