Catalog Number

8900

Brand Name

Rescuer Nebulizer Kit for CPAP Systems

Version/Model Number

8900

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

-

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

CCQ

Product Code Name

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Public Device Record Key

a5803382-f94e-4e6a-8bcd-3481a28204cc

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 03, 2018

Package DI Number

B00289001

Quantity per Package

6

Contains DI Package

B00289000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag