Thinklabs

GUDID 00899529001106

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.

THINKLABS MEDICAL, LLC

Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope
Primary Device ID00899529001106
NIH Device Record Key22da8d0c-8c99-489b-bb9d-a9d3a762e148
Commercial Distribution Discontinuation2050-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameThinklabs
Version Model NumberOne
Company DUNS011804706
Company NameTHINKLABS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com
Phone1 800 918 1088
Emailsupport@thinklabs.com

Device Dimensions

Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch
Weight0.075 Pound
Height1.2 Inch
Outer Diameter1.75 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit
Handling Environment TemperatureBetween 0 Degrees Fahrenheit and 130 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]
GS100899529001106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic
DQDStethoscope, Electronic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-02-22
Device Publish Date2016-09-19

Trademark Results [Thinklabs]

Mark Image

Registration | Serial
Company
Trademark
Application Date
THINKLABS
THINKLABS
85237461 4242643 Dead/Cancelled
ALTAIR ENGINEERING, INC.
2011-02-09
THINKLABS
THINKLABS
78309246 2973883 Live/Registered
THINKLABS MEDICAL, LLC
2003-10-03
THINKLABS
THINKLABS
74115945 1726457 Dead/Cancelled
THINKLABS INCORPORATED
1990-11-16

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