Center Health Blood Glucose Test Strips (50pcs/bot

GUDID 04713106027180

CENTER HEALTH INCORPORATED

Glucose IVD, kit, electrometry
Primary Device ID04713106027180
NIH Device Record Key0f006a53-5869-45ac-bf0f-9f549692b2d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameCenter Health Blood Glucose Test Strips (50pcs/bot
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104713106027180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-02-28
Device Publish Date2019-01-28

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
04713106027173 - Center Health Nano Smart Dongle Blood Glucose Moni2019-02-28
04713106027180 - Center Health Blood Glucose Test Strips (50pcs/bot2019-02-28
04713106027180 - Center Health Blood Glucose Test Strips (50pcs/bot2019-02-28

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