Catalog Number

-

Brand Name

NEW TRANSPARENT SILICONE MASK SIZE#3.CHILD LARGE

Version/Model Number

SM-86533

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

-

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

-

Product Code

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Public Device Record Key

210c4955-7b3c-4019-b18d-a5f68980cde0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-