AccessGUDID - DEVICE: Braun (00328785000511)

GUDID

Device Identifier (DI) Information

Brand Name: Braun
Version or Model: PRO6000BSNAV2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KAZ USA, INC.

Primary DI Number: 00328785000511
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 Accessory Thermometry, Charging Station, to be used with PRO6000 ear thermometer.

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?
35396	Thermometer holder	A device specifically designed to hold a patient thermometer. It can be, e.g., a small container to put the thermometer in or a holder affixed to, e.g., a wall upon which the thermometer is placed (housed). This device will often be considered to be an accessory to the GMDN code of the parent device. It is typically made of plastic, glass or metal and is used to protect the thermometer from damage and maintain it in a hygienic condition while it is not being used.	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
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 42108f17-7ac4-421e-b12a-90e72923fcb7
Public Version Date: May 27, 2020
Public Version Number: 3
DI Record Publish Date: August 29, 2016