AccessGUDID - DEVICE: Braun (00328785000344)

GUDID

Device Identifier (DI) Information

Brand Name: Braun
Version or Model: PRO6000KSNA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KAZ USA, INC.

Primary DI Number: 00328785000344
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 122612547 *Terms of Use

Device Description: Braun ThermoScan PRO6000 Ear Thermometer with Small Cradle & Charging Station - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" with UDI Datamatrix 00328785000252 and a box of 20 probe covers.

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:	Yes
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?
17887	Infrared patient thermometer, ear	A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. 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
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between .7 and 1.06 KiloPascal
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -13 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5f972f5d-516c-4822-a448-85ef5cc95b54
Public Version Date: May 27, 2020
Public Version Number: 3
DI Record Publish Date: August 29, 2016