Catalog Number

-

Brand Name

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

Version/Model Number

1454015

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

Yes

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

-

FDA Premarket Submission

K911422

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

03ec2e27-fd2e-44a1-bb46-571a0824ff8e

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-