DEVICE: Stat-Skan® (B2391150B1)

Device Identifier (DI) Information

Stat-Skan®
1150-B
In Commercial Distribution
1150-B
TRADEMARK MEDICAL, L.L.C.
B2391150B1
HIBCC

100
024113805 *Terms of Use
Liquid crystal temperature monitor strip (round), individually wrapped, dispenser box
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Liquid-crystal patient thermometer, single-use A device designed to measure skin temperature at several different points using liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band applied to the forehead. It is intended to indicate the presence or absence of fever, or to monitor body temperature. The device may be used in the home. This is a single-use device.
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FDA Product Code

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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

cee1d1a0-c390-48c0-8ce3-b8f1473948c1
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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: B2391150B0 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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