Catalog Number

-

Brand Name

Altera

Version/Model Number

678G1002

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

K100380,K100380

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

ae68c1e6-f4ce-4bf9-a86c-a611d03dc705

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2016

Package DI Number

00744229678304

Quantity per Package

12

Contains DI Package

00744229678021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton