DEVICE: Crystaline II (10815236020152)
Device Identifier (DI) Information
Crystaline II
5101SB-II
In Commercial Distribution
SSH5101-SB-12
LCR HALLCREST, LLC.
5101SB-II
In Commercial Distribution
SSH5101-SB-12
LCR HALLCREST, LLC.
Crystaline II Liquid Crystal Temperature Trend Indicators - Poly Bag of 2
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33618 | Liquid-crystal patient thermometer, single-use |
A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KPD | Strip, Temperature, Forehead, Liquid Crystal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity |
Storage Environment Temperature: between 60 and 104 Degrees Fahrenheit |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b13abf21-85f3-4ea9-b002-11fe15c9a234
February 24, 2020
3
September 23, 2016
February 24, 2020
3
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00815236020155
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-325-3671
mailbox@sharn.com
mailbox@sharn.com