Catalog Number

15350

Brand Name

Thumper

Version/Model Number

1007CC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K851139

Product Code

DRM

Product Code Name

Compressor, Cardiac, External

Public Device Record Key

863ba9a8-47b4-44f5-ba59-1f37b4d34894

Public Version Date

July 18, 2018

Public Version Number

4

DI Record Publish Date

September 12, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-