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| Primary Device ID | 00899529001106 |
| NIH Device Record Key | 22da8d0c-8c99-489b-bb9d-a9d3a762e148 |
| Commercial Distribution Discontinuation | 2050-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thinklabs |
| Version Model Number | One |
| Company DUNS | 011804706 |
| Company Name | THINKLABS MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com | |
| Phone | 1 800 918 1088 |
| support@thinklabs.com |
Device Dimensions
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
| Weight | 0.075 Pound |
| Height | 1.2 Inch |
| Outer Diameter | 1.75 Inch |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Fahrenheit and 130 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00899529001106 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K032230
FDA Product Code
| DQD | Stethoscope, Electronic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2021-02-22 |
| Device Publish Date | 2016-09-19 |
Trademark Results [Thinklabs]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THINKLABS 85237461 4242643 Dead/Cancelled |
ALTAIR ENGINEERING, INC. 2011-02-09 |
 THINKLABS 78309246 2973883 Live/Registered |
THINKLABS MEDICAL, LLC 2003-10-03 |
 THINKLABS 74115945 1726457 Dead/Cancelled |
THINKLABS INCORPORATED 1990-11-16 |
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