Catalog Number

na

Brand Name

LC Sprint

Version/Model Number

022F35-PRO

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

K060399,K060399

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

dc0104f9-7fe0-4f88-99ba-19b12029e918

Public Version Date

April 15, 2020

Public Version Number

1

DI Record Publish Date

April 07, 2020

Package DI Number

00744229100737

Quantity per Package

50

Contains DI Package

00744229230199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton