TruLock

GUDID 50850058254376

TruLock™ Pediatric Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Pediatric Foam Base, and Skin Prep Pad

HR PHARMACEUTICALS INC.

Personal device holder, reusable

• Primary Device ID: 50850058254376
• NIH Device Record Key: 1568106b-486b-48f2-aa7c-77d02df94acb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruLock
• Version Model Number: TLFCP
• 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
• 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	00850058254371 [Primary]
GS1	10850058254378 [Package]; Contains: 00850058254371; Package: Box [25 Units]; In Commercial Distribution
GS1	50850058254376 [Package]; Contains: 10850058254378; Package: Case [4 Units]; In Commercial Distribution

FDA Product Code

• EYJ: HOLDER, URETERAL CATHETER

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: 2025-03-11
• Device Publish Date: 2025-03-03

On-Brand Devices [TruLock]

• 50850058254376: TruLock™ Pediatric Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Pediatric F
• 10850058254361: TruLock™ Foley Securement Device, For 3-Way Foley,3-Way Swivel Clamp on Mesh Cloth Base, and S
• 10850058254330: TruLock™ Foley Securement Device, For 2-Way Foley, Large Swivel Clamp on Mesh Cloth Base, and