Catalog Number

-

Brand Name

ResQCPR System

Version/Model Number

12-0825-000

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"

Yes

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

PIZ

Product Code Name

Combination Compression/Decompression Manual Chest Pump With Impedance Respiratory Valve

Public Device Record Key

8f8e8ef6-26d2-4d4d-8065-768da0ce67eb

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 19, 2016

Package DI Number

M5921208220000

Quantity per Package

2

Contains DI Package

M5921208250001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-