DIABIMETRICS Blood Glucose Monitoring System

GUDID 00860009958012

Meter*1 Lancing Device*1 Sterile Lancets*10

Health For Mankind Company

Glucose monitoring system IVD, home-use
Primary Device ID00860009958012
NIH Device Record Key650b3d88-7b34-444a-af9f-8d1ce5ef758d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIABIMETRICS Blood Glucose Monitoring System
Version Model NumberTD-4143
Company DUNS118241968
Company NameHealth For Mankind Company
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 Numbertrue
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
GS100860009958012 [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 Date2024-01-31
Device Publish Date2024-01-23

Devices Manufactured by Health For Mankind Company

00860009958012 - DIABIMETRICS Blood Glucose Monitoring System2024-01-31Meter*1 Lancing Device*1 Sterile Lancets*10
00860009958012 - DIABIMETRICS Blood Glucose Monitoring System2024-01-31 Meter*1 Lancing Device*1 Sterile Lancets*10
00860009958029 - DIABIMETRICS Blood Glucose Test Strips (50PCS)2024-01-31

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