Catalog Number

6001486N

Brand Name

SWAROMED

Version/Model Number

4111

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"

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

bc3624d3-248c-4427-9de1-b86719111103

Public Version Date

May 13, 2019

Public Version Number

1

DI Record Publish Date

May 03, 2019

Package DI Number

39120026223718

Quantity per Package

12

Contains DI Package

29120026223711

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton