TruLock

Basic Information

• Brand Name: TruLock
• Primary DI: 00850058254333
• Version / Model: TLFC1
• Company Name: HR PHARMACEUTICALS INC.
• Labeler DUNS: 828918164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-03
• Public Version: 1
• Public Version Date: 2025-03-11
• Public Version Status: New
• Public Device Record Key: 0bff74bb-98ac-4875-a10f-3ed3953f62a0

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EYJ	HOLDER, URETERAL CATHETER	Gastroenterology, Urology	876.5130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37685	Personal device holder, reusable	A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850058254330	GS1	Box	25	In Commercial Distribution
Primary	00850058254333	GS1
Package	50850058254338	GS1	Case	4	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 110
• Email: [email protected]