GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT) 3S-01-14010J

GUDID 04711200722291

GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT)

HMD BIOMEDICAL INC.

Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry
Primary Device ID04711200722291
NIH Device Record Keyf5711638-bb88-4841-9b2b-e0f806f90c54
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlucoLeader Enhance Blood Glucose Test Strip(BR/BMT)
Version Model Number3S-01-14010J
Catalog Number3S-01-14010J
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 35.6 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100389154000884 [Package]
Package: BOX [540 Units]
In Commercial Distribution
GS100389154000884 [Package]
Package: BOX [540 Units]
In Commercial Distribution
GS104711200722291 [Primary]
GS104711200722291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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.

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04711200722291 - GlucoLeader Enhance Blood Glucose Test Strip(BR/BMT)2020-05-19 GlucoLeader Enhance Blood Glucose C4H vial packed test strip(BR/BMT)
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