Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277027960
• Version / Model: 8600-01165
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-14
• Public Version: 4
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: cc5516ad-a092-4cd0-84fa-155d500bec13

Device Description

*Custom Kit* Rhema Scientific Glucose 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
CFW	COPPER REDUCTION, GLUCOSE	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34864	Adhesive bandage	A sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). This is a single-use device.	No	Active
17988	Antiseptic skin towelette	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 small, absorbent, sterile cloth, usually made of cotton, that is pre-treated and sealed in an individual package. It is 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
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.	No	Active
61579	Blood lancet, single-use	A sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815277027960	GS1