AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094325317)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06000-100
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094325317
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Braun Thermoscan Pro 6000 Ear Thermometer Charging Station, North America (#104894 Rechargeable battery and #105785 Powercord 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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
13116	Electronic thermometer probe cover	A device intended to be used as a physical barrier between the patient and the probe of a thermometer that uses electronics to create the measurement, e.g., a tympanic (in-the-ear) or electronic (body) thermometer, to prevent cross-contamination between patients. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, electronic, clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152748	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: afbfe5e8-96bd-43d1-a8a1-d4d7e70c9d35
Public Version Date: April 02, 2021
Public Version Number: 1
DI Record Publish Date: March 25, 2021