TempAlert II 8501-II-CE

GUDID 00815236020322

TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked

LCR HALLCREST, LLC.

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Primary Device ID00815236020322
NIH Device Record Key0744809f-66c0-4034-a9b8-bbc8769740b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameTempAlert II
Version Model Number8501-II-CE
Catalog Number8501-II-CE
Company DUNS059247507
Company NameLCR HALLCREST, LLC.
Device Count100
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com
Phone1-800-325-3671
Emailmailbox@sharn.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity
Storage Environment TemperatureBetween 60 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100815236020322 [Unit of Use]
GS130815236020323 [Primary]
GS140815236020320 [Package]
Contains: 30815236020323
Package: Outer Box [1 Units]
In Commercial Distribution

FDA Product Code

KPDStrip, Temperature, Forehead, Liquid Crystal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-03
Device Publish Date2020-10-26

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20815236020319TempAlert II Liquid Crystal Temperature Trend Indicator
00815236020322TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked
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