Braun

Basic Information

• Brand Name: Braun
• Primary DI: 00328785000344
• Version / Model: PRO6000KSNA
• Company Name: KAZ USA, INC.
• Labeler DUNS: 122612547
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-29
• Public Version: 3
• Public Version Date: 2020-05-27
• Public Version Status: Update
• Public Device Record Key: 5f972f5d-516c-4822-a448-85ef5cc95b54

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

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00328785000344	GS1
Package	10328785000341	GS1	Case	18	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: .7 – 1.06 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -13 – 131 Degrees Fahrenheit