ODM 99GM282DR1

GUDID 00883489002396

1 meter - 00883489002396

BIONIME CORPORATION

Glucose monitoring system IVD, home-use
Primary Device ID00883489002396
NIH Device Record Key7597efce-d860-4e0e-9c08-9b932eadb7e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameODM
Version Model NumberDiathrive+ Bluetooth Blood Glucose Monitoring Syst
Catalog Number99GM282DR1
Company DUNS658637244
Company NameBIONIME CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone866-878-7477
Emailcustomerservice@diathrive.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100883489002396 [Primary]
GS100883489002402 [Package]
Package: box [1 Units]
In Commercial Distribution
GS120883489002406 [Package]
Contains: 00883489002402
Package: Box [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2020-01-27
Device Publish Date2020-01-17

On-Brand Devices [ODM]

00883489001542iGlucose test strips
00883489001504The combination products includes 1 pce of lancing device_GD500(00883489001566), 1 pc of control
2088348900242025 strips - 80883489002415
008834890023961 meter - 00883489002396
208834890023831 meter - 00883489002372

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.