DEVICE: PC600 Digital Thermometer - White (00030028000041)

Device Identifier (DI) Information

PC600 Digital Thermometer - White
PC600
In Commercial Distribution
PC600
Broder Bros., Co.
00030028000041
GS1

1
005381652 *Terms of Use
PC600 Digital Thermometer - White • ABS Plastic thermometer with 1 button cell battery (AG3), replaceable. • Each thermometer comes in 2-piece plastic storage case. Imprint on case only. • Power/Technology: Range 90.0 108.0 F. Accuracy - 0.3 F Less than 95.0 F, 0.2 F 95.0 F to 102.0 F, 0.3 F Greater than 102.0 F. Measures 77.0 F at standard room temperature. • Refer to instructions (included) for cleaning. • Features On/Off switch and 3 1/2 digit LCD display. • For oral and under-arm use only. • Takes approx. 10 seconds to read temperature, at which time device emits beeping sound. Temperature shows on display 30-60 seconds after sound goes off.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
No
No
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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

14c2a23f-278e-49b4-9670-b860db3de461
March 29, 2018
2
January 09, 2017
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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
20030028000045 300 10030028000048 In Commercial Distribution Case
10030028000048 10 00030028000041 In Commercial Distribution Inner 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)

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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

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1-877-858-9908
customerservice@jetlinepromo.com
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