AccessGUDID - DEVICE: Geratherm Daisy Color Pacifier Digital Thermometer (00614801300704)

GUDID

Device Identifier (DI) Information

Brand Name: Geratherm Daisy Color Pacifier Digital Thermometer
Version or Model: RETAIL Baby Pacifier Thermometer
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 30070
Company Name: R.G. ENTERPRISES (U.S.A.), INC.

Primary DI Number: 00614801300704
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 928998905 *Terms of Use

Device Description: Daisy Infant Pacifier Thermometer is a clinical thermometer intended for the measurement of oral body temperature in infants and young children. The device is waterproof, uses a CR2032 (3 V) battery. Dimensions: 60 mm x 50 mm x 42 mm. Weight: Approx. 23 grams (including battery). Beeper: Approx. 5 secs. sound signal when end temperature reached. Memory: Built-in memory enabling display of the previously measured value. Shut-off: Automatic shut-off in approx. 30 seconds. Backlight Color Coded Visual fever alarm indicators green yellow and red : 36,0 T 37,1 green 37,2 T 37,4 yellow 37,5 T 43,9 red A protective storage cover included

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:	Yes
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 [?]
K981456	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: 82701603-16e2-4dc4-af48-e3a0c510b09c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016