DEVICE: Digital Thermometer (00030028000010)

Device Identifier (DI) Information

Digital Thermometer
PL-1815
In Commercial Distribution
PL-1815
Broder Bros., Co.
00030028000010
GS1

1
005381652 *Terms of Use
PL-1815 Digital Thermometer {Previously Points Of Light NO. THERM} Features an easy-to-read LCD display, meets FDA requirements and Includes automatic switch-off feature COLOR: RED
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Intermittent electronic patient thermometer A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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

7ebef740-bf38-4425-9833-74612e5f012d
March 29, 2018
2
September 14, 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
10030028000017 15 00030028000010 In Commercial Distribution Inner Box
20030028000014 300 10030028000017 In Commercial Distribution Case
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-800-873-7746
customerservice@primeline.com
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