Catalog Number

8805-NK

Brand Name

Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit

Version/Model Number

8805-NK

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

K122610,K122610

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

e15511e8-0ac9-4518-a2f3-05e2c98ff754

Public Version Date

November 02, 2018

Public Version Number

1

DI Record Publish Date

October 02, 2018

Package DI Number

B0028805NK1

Quantity per Package

6

Contains DI Package

B0028805NK0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case