AccessGUDID - DEVICE: CorTemp (00857414006018)

GUDID

Device Identifier (DI) Information

Brand Name: CorTemp
Version or Model: HT150031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: H Q, INC

Primary DI Number: 00857414006018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185719606 *Terms of Use

Device Description: A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 300 kHz frequency and transmits via near field magnetic link..

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55824	Temperature telemetric monitoring system transmitter	A body-worn, battery-powered component of a temperature telemetric monitoring system designed to continuously measure and wirelessly transmit core and/or skin temperature signals to the system's receiver. It typically consists of a portable radio transmitter to which are attached skin, tympanic, rectal, oesophageal, and/or ingestible temperature sensors. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K880639	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2f12c20-3bda-44c1-8463-41b215711b43
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 28, 2017