Catalog Number

HCSU4482

Brand Name

Medline

Version/Model Number

HCSU4482

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"

Yes

For Single-Use

Yes

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

K091272

Product Code

CAF

Product Code Name

Nebulizer (direct patient interface)

Public Device Record Key

b05122f6-9eaa-4f61-b8b8-05526150b3fb

Public Version Date

August 31, 2020

Public Version Number

1

DI Record Publish Date

August 21, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-