Kosmos Torso - Refurbished - ECHONOUS, INC.

Duns Number:080481089

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More Product Details

Catalog Number

-

Brand Name

Kosmos Torso - Refurbished

Version/Model Number

R006025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K193518

Product Code Details

Product Code

DQD

Product Code Name

Stethoscope, Electronic

Device Record Status

Public Device Record Key

4a84a132-be59-4014-a0e3-3a7f3ce34b62

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ECHONOUS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 46