Catalog Number

LF-192

Brand Name

AincA®

Version/Model Number

LF-192

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

-

FDA Premarket Submission

-

Product Code

CCQ

Product Code Name

NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Public Device Record Key

729f8fd6-fca5-4d66-8882-d5c0de27e42c

Public Version Date

June 08, 2021

Public Version Number

2

DI Record Publish Date

March 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-