Catalog Number

10550994080

Brand Name

AEROECLIPSE BAN Replacement Mouthpiece Assembly

Version/Model Number

105509

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 24, 2020

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080926,K080926

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

98cbf587-7af3-4be1-ab6b-64547782a91d

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 24, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-