Center Health Blood Glucose Monitoring System

GUDID 04710469871498

CENTER HEALTH INCORPORATED

Glucose analyser IVD, home-use
Primary Device ID04710469871498
NIH Device Record Key526becd9-5908-4595-ab9d-eaed4e14e8a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenter Health 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
GS104710469871498 [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 Date2019-10-09
Device Publish Date2019-10-01

Devices Manufactured by CENTER HEALTH INCORPORATED

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

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