Catalog Number

1

Brand Name

Holter Monitor

Version/Model Number

Model 950-3CH

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 15, 2029

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

DSH

Product Code Name

Recorder, Magnetic Tape, Medical

Public Device Record Key

cb54d5d0-a772-4a13-9e03-411a7b0cb6ff

Public Version Date

November 25, 2019

Public Version Number

1

DI Record Publish Date

November 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-