Catalog Number

-

Brand Name

Draeger 5-Lead ECG - Reprocessed

Version/Model Number

RM-MP00881

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

Yes

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

-

Product Code

IKD

Product Code Name

Cable, Electrode

Public Device Record Key

ca2e5f64-bf19-4839-8ba4-eee0f96bebfa

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

10816317023963

Quantity per Package

20

Contains DI Package

00816317023966

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case