Catalog Number

-

Brand Name

CIRRUS2 NEBULISER, PAEDIATRIC, INTERSURGICAL ECOLITE MASK KIT WITH TUBE 2.1M

Version/Model Number

1454013

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K911422,K911422

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

3f12967f-7100-4b1f-9d01-6e5611ebf904

Public Version Date

October 26, 2022

Public Version Number

1

DI Record Publish Date

October 18, 2022

Package DI Number

05030267122554

Quantity per Package

36

Contains DI Package

05030267122547

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-