AccessGUDID - DEVICE: Thinklabs (00899529001106)

GUDID

Device Identifier (DI) Information

Brand Name: Thinklabs
Version or Model: One
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THINKLABS MEDICAL, LLC

Primary DI Number: 00899529001106
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2050
Device Count: 1
Labeler D-U-N-S® Number*: 011804706 *Terms of Use

Device Description: The Thinklabs One Digital Stethoscope is intended for use as a diagnostic aid in patient diagnosis. It can be used for the amplification of heart, lung, and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any use except as indicated. The Thinklabs One is designed to be used by medical and allied professionals and trainees enrolled in professional training programs. Operation of the device requires no special training beyond the user following the instructions for use on Thinklabs website. Accurate patient diagnosis with a stethoscope requires the operator to have auscultation skills.

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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032230	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
Handling Environment Temperature: between 0 and 130 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 0.075 Pound
Height: 1.2 Inch
Outer Diameter: 1.75 Inch

Device Record Status

Public Device Record Key: 22da8d0c-8c99-489b-bb9d-a9d3a762e148
Public Version Date: November 25, 2024
Public Version Number: 6
DI Record Publish Date: September 19, 2016