Tenex Health TX® 554-0001-001

GUDID 00857156006291

TX Foot Pedal

TENEX HEALTH, INC.

Ultrasonic suction system

• Primary Device ID: 00857156006291
• NIH Device Record Key: bfb6d7e3-deed-4178-be91-505e8db05db5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenex Health TX®
• Version Model Number: 554-0001-001
• Catalog Number: 554-0001-001
• Company DUNS: 038720788
• Company Name: TENEX HEALTH, 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com
• Phone: 9494547500
• Email: regulatory@tenexhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857156006291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123640

FDA Product Code

• LFL: Instrument, Ultrasonic Surgical

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: 2020-07-23
• Device Publish Date: 2020-07-15

On-Brand Devices [Tenex Health TX®]

• 00857156006246: TX1 Procedure Pack, Shelf Pack, No Supply Kit
• 00857156006185: TX2 Procedure Pack, Shelf Pack, No Supply Kit
• 00857156006123: TX-Bone (TXB) Procedure Pack, Shelf Pack, No Supply Kit
• 00857156006338: Inflation Cuff, 1000cc
• 00857156006321: Inflation Cuff, 500cc
• 00857156006314: Travel Case
• 00857156006307: TX System Console
• 00857156006291: TX Foot Pedal
• 00857156006277: Power Cord, 120V, USA
• 00857156006260: Fuse Set, 5 X 20, 250V, T5A (Set of 2)
• 00857156006222: TX1 Procedure Pack
• 00857156006208: TX1 MicroTip
• 00857156006161: TX2 Procedure Pack
• 00857156006147: TX2 MicroTip
• 00857156006109: TX-Bone (TXB) Procedure Pack
• 00857156006086: TX Supply Kit
• 00857156006079: TX-Bone (TXB) MicroTip
• 00857156006352: Power Cord, 220V, Europe