Catalog Number

-

Brand Name

Lamira

Version/Model Number

078F2671

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

cce08f6e-66e8-4282-8ed3-394388a150a9

Public Version Date

February 08, 2019

Public Version Number

1

DI Record Publish Date

January 08, 2019

Package DI Number

00744229100683

Quantity per Package

160

Contains DI Package

00744229789116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton