Catalog Number

-

Brand Name

LC Sprint

Version/Model Number

023F35-R

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

c347cb2b-e279-4339-a03a-ee375e2a6548

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

00744229100232

Quantity per Package

12

Contains DI Package

00744229230113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton