Catalog Number

1125850

Brand Name

ISG Mouthpiece Mask Adapter Assembly

Version/Model Number

00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2100

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

K170853

Product Code

CAF

Product Code Name

NEBULIZER (DIRECT PATIENT INTERFACE)

Public Device Record Key

3d9b1b28-23ec-43c4-9c24-4c724561438f

Public Version Date

December 10, 2018

Public Version Number

1

DI Record Publish Date

November 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-