Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00817617022864
• Version / Model: 533-MS-001PMP
• Catalog Number: 533-MS-001PMP
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-04
• Public Version: 3
• Public Version Date: 2023-12-06
• Public Version Status: Update
• Public Device Record Key: da78703f-d713-48e7-8df1-4f7a6ed0696f

Device Description

Pump, Suction, Manual

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• 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
BSY	CATHETERS, SUCTION, TRACHEOBRONCHIAL	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63644	Emergency airway clearance suction pump, manual	A manually-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure for emergency aspiration of fluids, secretions, or other unwanted materials from the airway of a patient. It is typically used during patient transport or for emergency situations (e.g., placed on a crash cart); it is not intended for surgical use. It may include collection containers, microbial filter, valve, or tubing; it does not include patient contact devices (e.g., tips, catheters). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817617023342	GS1	CS	10	In Commercial Distribution
Primary	00817617022864	GS1