Primary Device ID | 20883489001850 |
NIH Device Record Key | 0b4f421a-f4eb-49fc-9ecc-664317b1b2b5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RIGHTEST GT333 Blood Glucose Monitoring System |
Version Model Number | Meter |
Company DUNS | 658637244 |
Company Name | BIONIME CORPORATION |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
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 | 00883489001849 [Primary] |
GS1 | 00883489001856 [Package] Contains: 00883489001849 Package: paper [1 Units] In Commercial Distribution |
GS1 | 20883489001850 [Package] Contains: 00883489001856 Package: paper [50 Units] In Commercial Distribution |
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 |
00883489002563 - GE | 2024-10-29 Kitbox |
00883489002525 - SMARTMETER | 2024-01-26 kit only has one meter |
00883489002501 - SMARTMETER | 2023-12-25 Control Solution-Level 2 |
00883489001306 - RIGHTEST | 2023-07-11 single lancing device |
00883489001320 - GE | 2023-07-11 GE Lancing device |
20883489002383 - ODM | 2020-01-27 1 meter - 00883489002372 |
00883489002396 - ODM | 2020-01-27 1 meter - 00883489002396 |
20883489002420 - ODM | 2020-01-27 25 strips - 80883489002415 |