DEVICE: Crystaline II (10815236020138)

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Device Record History
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Device Identifier (DI) Information
Crystaline II
5101-II
In Commercial Distribution
5101-II
LCR HALLCREST, LLC.
10815236020138
GS1

1
059247507 *Terms of Use
Crystaline II Liquid Crystal Temperature Trend Indicators - Envelope of 1
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
No
No
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KPD Strip, Temperature, Forehead, Liquid Crystal
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
3ea86e60-a982-444d-a533-f2d417a951c0
February 24, 2020
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
30815236020132 100 20815236020135 In Commercial Distribution Box
20815236020135 25 10815236020138 In Commercial Distribution Bag
40815236020139 100 10815236020138 In Commercial Distribution Bag
50815236020136 1000 40815236020139 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-325-3671
mailbox@sharn.com
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