GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ) 3K-01-140108

GUDID 04711200722246

GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/BMT)

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry
Primary Device ID04711200722246
NIH Device Record Key8337a70e-aca2-4f58-a201-4b1fa2214703
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)
Version Model Number3K-01-140108
Catalog Number3K-01-140108
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 8 Degrees Celsius and 44 Degrees Celsius
Storage Environment TemperatureBetween 46.6 Degrees Fahrenheit and 111.2 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 8 Degrees Celsius and 44 Degrees Celsius
Storage Environment TemperatureBetween 46.6 Degrees Fahrenheit and 111.2 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 8 Degrees Celsius and 44 Degrees Celsius
Storage Environment TemperatureBetween 46.6 Degrees Fahrenheit and 111.2 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000891 [Package]
Package: KIT [216 Units]
In Commercial Distribution
GS100389154000891 [Package]
Package: KIT [216 Units]
In Commercial Distribution
GS100389154000891 [Package]
Package: KIT [216 Units]
In Commercial Distribution
GS104711200722246 [Primary]
GS104711200722246 [Primary]
GS104711200722246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBWSystem, Test, Blood Glucose, Over The Counter
NBWSystem, Test, Blood Glucose, Over The Counter
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 Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by HMD BIOMEDICAL INC.

04711200722246 - GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)2020-05-19GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/BMT)
04711200722246 - GlucoLeader Enhance Blood Glucose Monitoring System(BR/IQ)2020-05-19 GlucoLeader Enhance P5 Blood Glucose Monitoring System (BR/BMT)
04711200722291 - GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT)2020-05-19 GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT)
03894540005253 - Rosie SmartMeter Professional Strip2019-12-27 Rosie SmartMeter Professional Strip-Foil
03891450006004 - GL GoodLife Blood Glucose Test Strip2019-12-27 GL GoodLife Blood Glucose Test Strip(AC-302)
00868665000045 - Rosie SmartMeter NFC Professional 2019-08-09 Rosie SmartMeter NFC Professional Blood Glucose Meter
00868665000076 - Rosie SmartMeter Test Strips 50ct(vial)2019-08-09 Rosie SmartMeter Blood Glucose GDH-FAD Test Strips
00389154000389 - Rosie SmartMeter 2019-08-09 Rosie SmartMeter Blood Glucose Monitoring System
00389154000501 - Rosie SmartMeter2019-08-09 Rosie SmartMeter NFC Professional Blood Glucose Monitoring System (Rosie SmartMeter NFC Professional)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.