Thinklabs

Basic Information

• Brand Name: Thinklabs
• Primary DI: 00899529001106
• Version / Model: One
• Company Name: THINKLABS MEDICAL, LLC
• Labeler DUNS: 011804706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 22da8d0c-8c99-489b-bb9d-a9d3a762e148
• Distribution End Date: 2050-12-31

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQD	Stethoscope, Electronic	Cardiovascular	870.1875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13754	Electronic stethoscope	An external electronic listening device designed to detect and amplify extremely weak body sounds that may be difficult to perceive when using a mechanical stethoscope. This device may differentiate between sound tones and accentuate one (e.g., blood flow through a defective heart valve) over another. 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 display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00899529001106	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032230	000

Device Sizes

Type	Value	Unit	Text
Weight	0.075	Pound
Height	1.2	Inch
Outer Diameter	1.75	Inch

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 0 – 130 Degrees Fahrenheit