Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277028271
• Version / Model: 024800P
• Catalog Number: 024800P
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-15
• Public Version: 3
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: b0317a1e-afc2-4934-921d-353ecd7f8c83

Device Description

Curaplex Laryngoscope Lite Blade and Handle Set Only

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: Yes
• 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
OGH	Laryngoscope kit	Anesthesiology	868.5540	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	00815277028271	GS1
Package	00810071639661	GS1	CS	20	In Commercial Distribution