EasyMax 15 Blood Glucose Test Strip

GUDID 01885017000170

10 strips in a vial

EPS BIO TECHNOLOGY CORP.

Glucose IVD, kit, enzyme spectrophotometry, rapid
Primary Device ID01885017000170
NIH Device Record Key51558420-ccb9-4ec7-86cf-0a9187c6bf0f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyMax 15 Blood Glucose Test Strip
Version Model NumberEM44
Company DUNS658620117
Company NameEPS BIO TECHNOLOGY CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone866-994-3345
Emailinfo@epsbio.com.tw

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100885017000171 [Primary]
GS101885017000170 [Package]
Contains: 00885017000171
Package: carton [30 Units]
In Commercial Distribution

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-12
Device Publish Date2018-10-12

On-Brand Devices [EasyMax 15 Blood Glucose Test Strip]

0088501700041650 strips in a vial
0188501700017010 strips in a vial

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