Catalog Number

-

Brand Name

DL950 Braemar Standard

Version/Model Number

900-0616-03

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K071733

Product Code

MWJ

Product Code Name

Electrocardiograph, Ambulatory (Without Analysis)

Public Device Record Key

20f85f99-3993-4341-93cf-fafbc55e7ef4

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

October 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-