Crystaline II 5101C-II-CE

GUDID 00815236020100

Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100 - CE Marked

LCR HALLCREST, LLC.

Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use Liquid-crystal patient thermometer, single-use
Primary Device ID00815236020100
NIH Device Record Keyb0633014-3fa3-47da-a7b5-9cdc0cf380c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCrystaline II
Version Model Number5101C-II-CE
Catalog Number5101C-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 Latexfalse
Labeled No Natural Rubber Latextrue
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
GS100815236020100 [Unit of Use]
GS130815236020101 [Primary]
GS150815236020105 [Package]
Contains: 30815236020101
Package: Outer Box [1 Units]
Discontinued: 2020-05-01
Not 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

On-Brand Devices [Crystaline II]

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10815236020152Crystaline II Liquid Crystal Temperature Trend Indicators - Poly Bag of 2
30815236020132Crystaline II Liquid Crystal Temperature Trend Indicators - Envelope of 1
10815236020121Crystaline II Liquid Crystal Temperature Trend Indicators - Box of 125
20815236020111Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 125
20815236020104Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100
20815236020098Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 50
20815236020081Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 25.
00815236020100Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100 - CE Marked
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