Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277021807
• Version / Model: 670135-KIT
• Catalog Number: 670135-KIT
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-16
• Public Version: 6
• Public Version Date: 2023-12-06
• Public Version Status: Update
• Public Device Record Key: 0518f83c-aef2-4211-8e3e-664c8efee2e3

Device Description

Curaplex BEMS Group UVC Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POQ	Blood transfusion kit	General Hospital	880.5440	2
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36257	Peripherally-inserted central venous catheter	A thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.	Yes	Active
13913	Antiseptic skin swab	A device that is pre-soaked with an antiseptic and intended to inhibit the growth of microorganisms on the skin; it may also include an anaesthetic to alleviate pain. It is typically designed as a sterile cotton swab (a pledget) on a plastic stick and used in the hospital environment, in the home, or carried for first aid to prevent infection and provide temporary pain and itching relief associated with minor cuts, scrapes, or burns. This is a single-use device.	No	Active
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815277021807	GS1
Package	00810094570859	GS1	CS	20	In Commercial Distribution