CARE-E-VAC 3

GUDID 00628101609351

Portable Suction Pump

OHIO MEDICAL, LLC

Emergency airway clearance suction system, electric

• Primary Device ID: 00628101609351
• NIH Device Record Key: 09a9922a-a938-4551-a0a0-162058e665d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARE-E-VAC 3
• Version Model Number: CARE-E-VAC 3
• 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	00628101609351 [Primary]
GS1	08688250002436 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062610

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

On-Brand Devices [CARE-E-VAC 3]

• 08688250002436: Portable Suction Pump
• 00628101609351: Portable Suction Pump