Catalog Number

-

Brand Name

SEER

Version/Model Number

1000

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

K130785

Product Code

MWJ

Product Code Name

ELECTROCARDIOGRAPH,AMBULATORY(WITHOUT ANALYSIS)

Public Device Record Key

a3ba6e1d-6660-445e-9636-0ebd79ca17e3

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

June 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-