TACVAC 510-0006-01

GUDID B3945100006010

Portable Battery Powered Suction Device

ATHENA GTX, INC.

Emergency airway clearance suction system, electric

• Primary Device ID: B3945100006010
• NIH Device Record Key: dd371c9c-0261-43c8-8bb7-7b13b64c5e9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TACVAC
• Version Model Number: Collection Unit
• Catalog Number: 510-0006-01
• Company DUNS: 048031913
• Company Name: ATHENA GTX, 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: true
• Lot Batch: true
• Serial Number: false
• 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: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com
• Phone: 515-288-3360
• Email: info@athenagtx.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3945100006010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153459

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: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2017-12-06

On-Brand Devices [TACVAC]

• B3945300021010: Portable Battery Powered Suction Device
• B3945100006010: Portable Battery Powered Suction Device