AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094201734)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 97200-MCL
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094201734
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Welch Allyn 3.5 V SureColor LED Diagnostic Set including Coaxial Ophthalmoscope (#11720-L), MacroView Otoscope with Throat Illuminator (# 23820-L), Rechargeable 60-Minute Power Handle(s) -- C-Cell Convertible, Hard Storage Case, C-Cell Battery Converter Accessory; Nickel-Cadmium (# 72300) 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?
17115	Noninvasive device battery charger	An electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ERA	OTOSCOPE

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: 2ab5a09f-bcac-4bc5-846c-71396d38df11
Public Version Date: June 28, 2022
Public Version Number: 4
DI Record Publish Date: September 17, 2016