Catalog Number

-

Brand Name

ALERTCARE

Version/Model Number

HL100A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081738,K081738,K081738

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

e4f28cd0-16f9-40e3-b902-56fc2946986d

Public Version Date

June 19, 2020

Public Version Number

1

DI Record Publish Date

June 11, 2020

Package DI Number

14719872486043

Quantity per Package

12

Contains DI Package

04719872486046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-