Catalog Number

-

Brand Name

Kosmos Bridge - Refurbished

Version/Model Number

R006030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

DPS

Product Code Name

Electrocardiograph

Public Device Record Key

6a9e2e5a-86b0-4863-a177-25c1a4725c50

Public Version Date

December 21, 2020

Public Version Number

1

DI Record Publish Date

December 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-