THE EDGE Blood Lactate Monitoring System

Basic Information

• Brand Name: THE EDGE Blood Lactate Monitoring System
• Primary DI: 04713648766530
• Version / Model: The EDGE meter
• Company Name: APEX BIOTECHNOLOGY CORP.
• Labeler DUNS: 657608092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-18
• Public Version: 1
• Public Version Date: 2021-01-26
• Public Version Status: New
• Public Device Record Key: dc11fddc-dd0d-4a45-b23f-871995c0a594

Device Description

KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• 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
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	862.1450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35885	Lactate monitoring system IVD, home-use	A collection of devices including a dedicated, portable, electrically-powered instrument (self-testing meter) reagents, test strips, and/or other associated disposable materials intended to be used for the quantitative measurement of lactate in a whole blood specimen.; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. It is typically used to monitor physical performance and conditioning in sport, and/or to support patient management.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04713648766530	GS1