Primary Device ID | 20883489001898 |
NIH Device Record Key | 136fc5a0-e62e-435d-bb36-3424377f3a32 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RIGHTEST GT333 Blood Glucose Test Strip |
Version Model Number | 50 PCS |
Company DUNS | 658637244 |
Company Name | BIONIME CORPORATION |
Device Count | 25 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Phone | 1 909 781 6969 |
info@bionimeusa.com |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00883489001887 [Primary] |
GS1 | 00883489001894 [Package] Contains: 00883489001887 Package: paper [2 Units] In Commercial Distribution |
GS1 | 10883489001891 [Package] Contains: 00883489001894 Package: paper [20 Units] In Commercial Distribution |
GS1 | 20883489001898 [Package] Contains: 10883489001891 Package: paper [12 Units] In Commercial Distribution |
GS1 | 80883489001883 [Unit of Use] |
NBW | System, Test, Blood Glucose, Over The Counter |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-10-16 |
Device Publish Date | 2019-10-08 |
20883489001911 | 100PCS |
20883489001898 | 50 PCS |
20883489001874 | 25pcs |