AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094014464)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901037
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20500H
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094014464
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Welch Allyn LumiView 3.5 V Halogen Portable Binocular Microscope with Headband, Portable Battery Pack (#75200), Reusable Ear Speculum Set (#22100); 120 V, 60 Hz AC, Nickel-Cadmium (#72250) Battery; IEC Plug Type-A

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?
36843	Mobile examination/treatment room light	A mobile device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJH	Loupe, binocular, low power

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 659377a9-b4a6-4224-b021-8e02066bf277
Public Version Date: March 26, 2025
Public Version Number: 2
DI Record Publish Date: August 15, 2023