TruAdvance

GUDID 50850058254864

TruAdvance™ 100% Silicone Foley Tray with Urine Meter

HR PHARMACEUTICALS INC.

Indwelling urethral catheterization kit, adult

• Primary Device ID: 50850058254864
• NIH Device Record Key: 86446599-f1da-417c-8f3b-5fe28a371860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruAdvance
• Version Model Number: FTSS16UM
• Company DUNS: 828918164
• Company Name: HR PHARMACEUTICALS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com
• Phone: +1(717)252-1110
• Email: sbenser@hrhealthcare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058254869 [Primary]
GS1	50850058254864 [Package]; Contains: 00850058254869; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• OHR: Catheter Care Tray

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-13
• Device Publish Date: 2025-08-05

On-Brand Devices [TruAdvance]

• 50850058254444: TruAdvance™ Foley Insertion Tray
• 50850045818284: TruAdvance™ Foley Insertion Tray
• 50850045818277: TruAdvance™ Foley Insertion Tray
• 50850045818260: TruAdvance™ Foley Insertion Tray
• 50850045818253: TruAdvance™ Foley Insertion Tray
• 50850058254840: TruAdvance™ 100% Silicone Foley Tray with Drainage Bag
• 50850058254833: TruAdvance™ 100% Silicone Foley Tray with Drainage Bag
• 50850058254826: TruAdvance™ 100% Silicone Foley Tray with Drainage Bag
• 50850058254871: TruAdvance™ 100% Silicone Foley Tray with Urine Meter
• 50850058254864: TruAdvance™ 100% Silicone Foley Tray with Urine Meter
• 50850058254857: TruAdvance™ 100% Silicone Foley Tray with Urine Meter
• 50850058254987: TruAdvance™ Add-A-Catheter Tray with Urine Meter
• 50850058254970: TruAdvance™ Add-A-Catheter Tray with Drainage Bag
• 50850058254765: TruAdvance™ Closed System Intermittent Catheter Tray