FIA Salut vial packed test strip(for SS) 3S-01-1400332

GUDID 04260236851326

FIA Salut Blood Glucose KPH vial packed test strip(for SS)

HMD BIOMEDICAL INC.

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Primary Device ID04260236851326
NIH Device Record Key76700177-6f43-4266-a842-41a14bd7aff6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFIA Salut vial packed test strip(for SS)
Version Model Number3S-01-1400332
Catalog Number3S-01-1400332
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 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851302 [Package]
Package: BOX [400 Units]
In Commercial Distribution
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]
GS104260236851326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose
LFRGlucose Dehydrogenase, Glucose

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [FIA Salut vial packed test strip(for SS)]

04260236851296FIA Salut Blood Glucose KPH vial packed test strip(for SS)
04260236851326FIA Salut Blood Glucose KPH vial packed test strip(for SS)

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