Catalog Number

-

Brand Name

Composite Respiratory Kit

Version/Model Number

0799

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"

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

K800562,K800562

Product Code

OGG

Product Code Name

Humidifier Nebulizer Kit

Public Device Record Key

87460ab2-3de6-4be2-a438-16296e42b014

Public Version Date

October 28, 2019

Public Version Number

1

DI Record Publish Date

October 18, 2019

Package DI Number

10709078007788

Quantity per Package

10

Contains DI Package

00709078007781

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-