AccessGUDID - DEVICE: CORE 500 Digital Stethoscope FIGS Earpiece

GUDID

Device Identifier (DI) Information

Brand Name: CORE 500 Digital Stethoscope FIGS Earpiece - Moss
Version or Model: E8
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAC500_FMO
Company Name: Eko Devices, Inc.

Primary DI Number: 00850010298313
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079670921 *Terms of Use

Device Description: CORE 500 Digital Stethoscope FIGS Earpiece - Moss

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
13754	Electronic acoustic stethoscope	An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQD	Stethoscope, Electronic
DPS	Electrocardiograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233609	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: d89d949f-6864-4af4-bec0-31c8d3013ee9
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025