DEVICE: Medline (00888277707958)

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Device Record History
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Device Identifier (DI) Information
Medline
SHNOTOUCH
In Commercial Distribution
SHNOTOUCH
MEDLINE INDUSTRIES, INC.
00888277707958
GS1

1
025460908 *Terms of Use
CTM THERMOMETER, FOREHEAD, NO TOUCH
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
No
Yes
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?
17888 Infrared patient thermometer, skin
A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FLL Thermometer, electronic, clinical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K122221 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between -4 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry, Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
b6f30cdc-11c5-413f-8015-9b509553ece5
February 28, 2024
2
December 24, 2020
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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
10888277707955 80 00888277707958 In Commercial Distribution CS
20888277707952 10 10888277707955 In Commercial Distribution BX
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Secondary DI

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

[?]
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)633-5463
service@medline.com
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