Center Health Nano Smart Dongle Blood Glucose Monitoring System

GUDID 00860003222300

CENTER HEALTH INCORPORATED

Glucose analyser IVD, home-use
Primary Device ID00860003222300
NIH Device Record Key3a7614aa-a802-4cf8-81d8-1264ec0c077f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenter Health Nano Smart Dongle Blood Glucose Monitoring System
Version Model NumberTD-4140
Company DUNS080946441
Company NameCENTER HEALTH INCORPORATED
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003222300 [Primary]

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 Date2020-03-25
Device Publish Date2020-03-17

Devices Manufactured by CENTER HEALTH INCORPORATED

00860003222324 - Center Health Smart Lightning dongle Blood Glucose Monitoring System2020-03-25
00860003222317 - Center Health Blood Glucose Test Strips (50pcs/bot)2020-03-25
00860003222300 - Center Health Nano Smart Dongle Blood Glucose Monitoring System2020-03-25
00860003222300 - Center Health Nano Smart Dongle Blood Glucose Monitoring System2020-03-25
04710469871498 - Center Health Blood Glucose Monitoring System2019-10-09
04713106027180 - Center Health Blood Glucose Test Strips (50pcs/bot2019-02-28
04713106027173 - Center Health Nano Smart Dongle Blood Glucose Moni2019-02-28

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.