Catalog Number

-

Brand Name

Lamira

Version/Model Number

078F3071

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"

-

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

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

e3af5f71-c73d-4cf3-a8a6-e9371eeae2f8

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Package DI Number

00744229100669

Quantity per Package

40

Contains DI Package

00744229789109

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton