AccessGUDID - DEVICE: OCCObaby (00850016971104)

GUDID

Device Identifier (DI) Information

Brand Name: OCCObaby
Version or Model: OCCOflex 43
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT-F10S-4333
Company Name: DEOCCO LLC

Primary DI Number: 00850016971104
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080378236 *Terms of Use

Device Description: Digital Thermometer enables fast and reliable measurements. These thermometers provide very high clinical accuracy and have been designed to provide maximum user-friendliness. Digital Thermometer series can be used in conjunction with or without a disposable probe cover when preferred. The basic principle of these thermometers is that a change of thermistor resistance, caused by changes in temperature, is converted to changes of frequency of R-C oscillator circuit. Therefore, the temperature can be given by measuring the frequency of the oscillator. For a given time period by applying to R-C oscillator circuit, changes of temperature will correspond to changes of pulse number.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
14035	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

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

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: 61cf49f8-812b-4185-8879-14cc7c1e61b5
Public Version Date: June 23, 2022
Public Version Number: 4
DI Record Publish Date: October 21, 2020