microdot Blood Glucose meter

GUDID 05060141250554

microdot Blood glucose monitoring system

CAMBRIDGE SENSORS LTD

Glucose monitoring system IVD, home-use
Primary Device ID05060141250554
NIH Device Record Key5a3d0d0e-fdf2-45d8-92b8-8c75d2d5df0a
Commercial Distribution StatusIn Commercial Distribution
Brand Namemicrodot Blood Glucose meter
Version Model Number100-01
Company DUNS770456226
Company NameCAMBRIDGE SENSORS LTD
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-Countertrue

Customer Support Contacts

Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com
Phone1-877-374-4062
Emailinfo@microdotcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105060141250554 [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 Date2022-04-12
Device Publish Date2022-04-04

Devices Manufactured by CAMBRIDGE SENSORS LTD

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35060141250494 - microdot xtra blood glucose test strip2022-04-12 microdot xtra blood glucose test strip for use with microdot xtra meter
05060141250530 - microdot xtra meter2022-04-12 microdot xtra blood glucose monitoring system
05060141250554 - microdot Blood Glucose meter2022-04-12microdot Blood glucose monitoring system
05060141250554 - microdot Blood Glucose meter2022-04-12 microdot Blood glucose monitoring system

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