TruAdvance

GUDID 50850058254840

TruAdvance™ 100% Silicone Foley Tray with Drainage Bag

HR PHARMACEUTICALS INC.

Indwelling urethral catheterization kit, adult

• Primary Device ID: 50850058254840
• NIH Device Record Key: 3734ef68-ab1b-41cd-a03a-f540474f7d9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruAdvance
• Version Model Number: FTSS18DB
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850058254845 [Primary]
GS1	50850058254840 [Package]; Contains: 00850058254845; 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: 2025-08-04
• Device Publish Date: 2025-07-25

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