Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277023917
• Version / Model: 16383
• 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: 4
• Public Version Date: 2023-02-20
• Public Version Status: Update
• Public Device Record Key: 36a3dae9-7b18-4fa4-87a4-608bc0cf0b35

Device Description

Curaplex Select Multi-Function Defib Pads, Physio-Control Pediatric 10pr/cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• 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
LDD	Dc-defibrillator, low-energy, (including paddles)	Cardiovascular	870.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11130	Electrode conductive skin pad, single-use	A noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00815277023924	GS1		10	In Commercial Distribution
Primary	00815277023917	GS1

Premarket Submissions

Submission Number	Supplement Number
K081442	000