Catalog Number

3607-04-15

Brand Name

Model 7700

Version/Model Number

3607-04-15

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K110987

Product Code

DRT

Product Code Name

Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Public Device Record Key

f75cc512-8bee-4858-8dd5-6c68f26240c0

Public Version Date

September 07, 2018

Public Version Number

1

DI Record Publish Date

August 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-