Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277027786
• Version / Model: 670005-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: 2016-12-14
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8fd93465-0be0-40c7-bcf3-e9c42aa25167

Device Description

Curaplex ALS Kit, BTM Sales Rep, incl Halo Seal, Burn Sheet, LMA, Blankets, Neb, Mask, Cannula, etc.

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
FMF	Syringe, piston	General Hospital	880.5860	2
POQ	Blood transfusion kit	General Hospital	880.5440	2
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2
FMI	Needle, hypodermic, single lumen	General Hospital	880.5570	2
MMK	Container, sharps	General Hospital	880.5570	2
DRX	Electrode, electrocardiograph	Cardiovascular	870.2360	2
FPB	Filter, infusion line	General Hospital	880.5440	2
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2
PEZ	Central venous catheter dressing change kit	General Hospital	880.5200	2
GJE	TRAY, BLOOD COLLECTION	Clinical Chemistry	862.1675	2
DXQ	blood pressure cuff	Cardiovascular	870.1120	2
FHM	APPARATUS, SUTURING, STOMACH AND INTESTINAL	General, Plastic Surgery	878.4800	1
BTM	Ventilator, emergency, manual (resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43000	First aid kit, non-medicated, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815277027786	GS1