Catalog Number

-

Brand Name

ACC Patient Interface Pad

Version/Model Number

RPP-G1000

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K141809,K141809

Product Code

DRM

Product Code Name

Compressor, Cardiac, External

Public Device Record Key

5c0f600d-19b7-46ef-8632-84fb7d27068b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 24, 2015

Package DI Number

20815098020588

Quantity per Package

3

Contains DI Package

00815098020584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-