Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00812277035100
• Version / Model: 8600-01393
• Catalog Number: 8600-01393
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 1
• Public Version Date: 2019-07-09
• Public Version Status: New
• Public Device Record Key: c8f32ca5-aa8b-4309-8e41-1bb231d6f2fe

Device Description

State of Nevada OEMS Pediatric ALS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAT	CANNULA, NASAL, OXYGEN	Anesthesiology	868.5340	1
LDE	STETHOSCOPE, MANUAL	Cardiovascular	870.1875	1
BTM	Ventilator, emergency, manual (resuscitator)	Anesthesiology	868.5915	2
CAE	AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY	Anesthesiology	868.5110	1
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2
FPK	Tubing, fluid delivery	General Hospital	880.5440	2
FPA	Set, administration, intravascular	General Hospital	880.5440	2
LRS	I.V. start kit	General Hospital	880.5200	2
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2
KGB	MASK, OXYGEN, NON-REBREATHING	Anesthesiology	868.5570	1
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2
DRX	Electrode, electrocardiograph	Cardiovascular	870.2360	2
FMF	Syringe, piston	General Hospital	880.5860	2
MMK	Container, sharps	General Hospital	880.5570	2
JOL	CATHETER AND TIP, SUCTION	General Hospital	880.6740	2
BYG	MASK, OXYGEN	Anesthesiology	868.5580	1
DXQ	blood pressure cuff	Cardiovascular	870.1120	2
NOD	Board, arm (with cover), non-sterile	General, Plastic Surgery	878.3910	1
GAA	NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44047	First aid kit, non-medicated, single-use	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812277035100	GS1