HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00810132043468
• Version / Model: 5000PB
• Company Name: Concordance Healthcare Solutions LLC
• Labeler DUNS: 080220245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2025-12-05
• Public Version: 1
• Public Version Date: 2025-12-15
• Public Version Status: New
• Public Device Record Key: efe92e5e-a34e-4f12-b538-9e0c1d4073a5

Device Description

1” x 18” Tourniquet, Textured, Latex Free, Hot Pink

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	878.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67048	Venous tourniquet, single-use	A device in the form of a narrow band or strap intended to be wrapped and manually tightened typically around a patient's arm to control/stop blood flow during collection of blood from a vein; it may additionally be used with a pressure bandage to apply pressure to a wound. It typically includes an adherent layer (e.g., Velcro) and/or a buckle mechanism for fastening/locking that allows adjustments to the degree of tightness; it is not fastened via a rotating handle mechanism (i.e., not a windlass). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810132043465	GS1	Case	4	In Commercial Distribution
Primary	00810132043468	GS1
Unit of Use	20810132043462	GS1