Perfect 3

Basic Information

• Brand Name: Perfect 3
• Primary DI: 04719871820247
• Version / Model: 6268
• Company Name: BIOTEST MEDICAL CORPORATION
• Labeler DUNS: 658447255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 18f48388-7737-421f-84d7-34272b4ba264

Device Description

Perfect 3 Meter Only

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	862.1660	1
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56685	Glucose analyser IVD, home-use/point-of-care, line-powered	A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by a layperson in the home or similar environment, or by health professionals at the point-of-care, for the quantitative in vitro measurement of glucose levels in whole blood. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719871820247	GS1