BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

EasyMax NG Self-Monitoring Blood Glucose System

DI: 00885017000065 · Model: EMMU · EPS BIO TECHNOLOGY CORP.

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: EasyMax NG Self-Monitoring Blood Glucose System
Primary DI: 00885017000065
Version / Model: EMMU
Company Name: EPS BIO TECHNOLOGY CORP.
Labeler DUNS: 658620117
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-12-12
Public Version: 3
Public Version Date: 2024-08-05
Public Version Status: Update
Public Device Record Key: dcc1eb8e-78b5-44d1-8c86-6c368134df29

Device Description

Semi kit: one blood glucose meter

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: Yes
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: Yes
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
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical 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. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885017000065	GS1
Package	01885017000064	GS1	carton	10	In Commercial Distribution
Package	10885017000062	GS1	carton	10	In Commercial Distribution

Customer Contacts

Phone: 866-994-3345
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121207	000

Storage Conditions

Type: Handling Environment Humidity
Temperature Range: – 90 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: 10 – 40 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: 2 – 30 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 40 – 85 Percent (%) Relative Humidity