AccessGUDID - DEVICE: IDx-DR (00860005195626)

GUDID

Device Identifier (DI) Information

Brand Name: IDx-DR
Version or Model: v2.3
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Digital Diagnostics Inc.

Primary DI Number: 00860005195626
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 028582271 *Terms of Use

Device Description: No description.

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?
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
PIB	Diabetic Retinopathy Detection Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213037	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: bc71d3b5-a68f-44a4-89d6-f0370f07adaa
Public Version Date: March 27, 2025
Public Version Number: 2
DI Record Publish Date: June 27, 2022

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: No
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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