AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094223910)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901108
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 411215
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094223910
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: RETINAVUE NETWORK SOFTWARE VERSION 3.X

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):	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?
58713	Retinal image analysis software	A software program intended to analyse images of the retina to provide interpretive results for clinical decision support relating to retinal diseases (e.g., diabetic retinopathy, choroidal neovascularization). It utilizes specific algorithms and/or artificial intelligence (AI) and deep learning techniques to assess and perform interpretation of diagnostic images acquired by retinal imaging devices (e.g., fundus camera, retinal optical coherence tomography system, ophthalmoscope) for early diagnosis and management of patients at risk.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFJ	System, image management, ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181016	000

Device Exempt from Premarket Submission: No 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: ff7f3f61-3283-4b3d-8fe3-a486aa4bceb2
Public Version Date: September 01, 2023
Public Version Number: 1
DI Record Publish Date: August 24, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(315)685-2834
Email: GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

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