Primary Device ID | 00885017000065 |
NIH Device Record Key | dcc1eb8e-78b5-44d1-8c86-6c368134df29 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EasyMax NG Self-Monitoring Blood Glucose System |
Version Model Number | EMMU |
Company DUNS | 658620117 |
Company Name | EPS BIO TECHNOLOGY CORP. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 866-994-3345 |
info@epsbio.com.tw |
Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885017000065 [Primary] |
GS1 | 01885017000064 [Package] Package: carton [10 Units] In Commercial Distribution |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-12-12 |
00885017000324 | 1 blood glucose meter; 10 strips in a vial; level 2 control solution, 10 lancets, 1 lancing devi |
00885017000065 | Semi kit: one blood glucose meter |