DEVICE: Electronic thermoneter (06932562310041)

Device Identifier (DI) Information

Electronic thermoneter
WT2
In Commercial Distribution

Guangdong Biolight Meditech Co., Ltd.
06932562310041
GS1

1
530120146 *Terms of Use
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
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
Continuous electronic patient thermometer, battery-powered A battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FLL Thermometer, Electronic, Clinical
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152739 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

959ebf4b-fa19-48b3-bb32-1a9b92ed45d9
July 06, 2018
3
September 22, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE