Andnesfit Health

GUDID 00146191202707

Blood Glucose Monitoring System

ANDESFIT LIMITED

Glucose monitoring system IVD, home-use
Primary Device ID00146191202707
NIH Device Record Keye3507f18-ebf5-43ec-91ca-37907f80780c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndnesfit Health
Version Model NumberADF-B27
Company DUNS664101036
Company NameANDESFIT LIMITED
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100146191202707 [Primary]

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 Date2019-10-22
Device Publish Date2019-10-14

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