DEVICE: Care Touch (00370393421011)

Device Identifier (DI) Information

Care Touch
ET-110
In Commercial Distribution

FUTURE DIAGNOSTICS LLC
00370393421011
GS1

1
080113296 *Terms of Use
Digital oral Thermometer
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
General-purpose patient temperature probe, reusable A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.
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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 [?]
K110776 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4b67c207-153f-46b8-a07e-923bedd88aeb
July 06, 2018
3
August 31, 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
20370393421015 300 00370393421011 In Commercial Distribution
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
646-773-5813
lenny@adelphiasupply.com
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