Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277021135
• Version / Model: 531502P
• 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: 3
• Public Version Date: 2019-08-21
• Public Version Status: Update
• Public Device Record Key: 67267ae1-f510-4e30-a5f5-c729ecac614e

Device Description

Curaplex CPAP Kit w/Bag, O2 Regulator and Cylinder

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAN	REGULATOR, PRESSURE, GAS CYLINDER	Anesthesiology	868.2700	1
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2
BYE	Attachment, breathing, positive end expiratory pressure	Anesthesiology	868.5965	2
BTL	Ventilator, emergency, powered (resuscitator)	Anesthesiology	868.5925	2
BYX	TUBING, PRESSURE AND ACCESSORIES	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36690	Cardiopulmonary resuscitation kit, reusable	A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in EMS vehicles for quick access in emergency situations. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815277021135	GS1