Catalog Number

6000611N

Brand Name

SWAROMED

Version/Model Number

1010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

4c3a6352-8e16-4b6b-a6aa-f74037d75d43

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 10, 2017

Package DI Number

39120026220632

Quantity per Package

12

Contains DI Package

29120026220635

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton