TrueCare Biomedix - USA

Basic Information

• Brand Name: TrueCare Biomedix - USA
• Primary DI: 10850789007991
• Version / Model: TCBTEC-10R
• Catalog Number: TCBTEC-10R
• Company Name: U.S. Infusion, LLC
• Labeler DUNS: 005457284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2025-09-09
• Public Version: 1
• Public Version Date: 2025-09-17
• Public Version Status: New
• Public Device Record Key: 60f16718-39bd-48e6-a89a-321939c7e137

Device Description

TAMPER EVIDENT CAP, LUER LOCK CAP, RED, 10-PACK, 400 PCS/BOX

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63614	Luer-formatted protective cap	A small, noninvasive, closed-ended Luer attachment intended to be attached to a luminal device (e.g., catheter, intravenous administration or pressure-monitoring tubing, syringe) with a Luer connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20850789007998	GS1	Case	400	In Commercial Distribution
Primary	10850789007991	GS1
Unit of Use	00850789007994	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]