AccessGUDID - DEVICE: Dreambaby (06970392210988)

GUDID

Device Identifier (DI) Information

Brand Name: Dreambaby
Version or Model: DMT-4726
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: JOYTECH HEALTHCARE CO.,LTD

Primary DI Number: 06970392210988
Issuing Agency: GS1
Commercial Distribution End Date: August 05, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 544392778 *Terms of Use

Device Description: The digital thermometers are intended to measure the human body temperature in regular mode orally, rectally or under the arm, And the devices are reusable for clinical or home use on people ofall ages, including children under 8 years old with adult supervision.

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: Yes 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: e70ed534-6c85-4163-a2f7-d255e65c32b8
Public Version Date: August 07, 2023
Public Version Number: 2
DI Record Publish Date: June 15, 2023