Instavac I

GUDID 08688250002580

Portable Suction Pump

OHIO MEDICAL, LLC

General-purpose surgical suction system, electric

• Primary Device ID: 08688250002580
• NIH Device Record Key: aa988724-3bca-4f43-a1d0-eb1236a5152d
• Commercial Distribution Discontinuation: 2020-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Instavac I
• Version Model Number: Instavac I
• 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	08688250002580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933902

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: 5
• Public Version Date: 2020-04-30
• Device Publish Date: 2017-01-05

On-Brand Devices [Instavac I]

• 08688250002580: Portable Suction Pump
• 00628101609504: Portable Suction Pump