GlucoLeader Enhance Blood Glucose Test Strip 3S-01-22X034

GUDID 04711200720068

GlucoLeader Enhance GL Blood Glucose Test Strip

HMD BIOMEDICAL INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use
Primary Device ID04711200720068
NIH Device Record Key4c43592b-a91f-4f83-8218-642ec1af8d96
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlucoLeader Enhance Blood Glucose Test Strip
Version Model Number3S-01-22X034
Catalog Number3S-01-22X034
Company DUNS658644174
Company NameHMD BIOMEDICAL INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200720068 [Primary]
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution
GS104711200723045 [Package]
Package: [200 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose
CGAGlucose Oxidase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

On-Brand Devices [GlucoLeader Enhance Blood Glucose Test Strip]

04711200722864GlucoLeader Enhance GL Blood Glucose Test Strip
04711200720068GlucoLeader Enhance GL Blood Glucose Test Strip

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