Catalog Number

DYNJAAMASK02

Brand Name

Medline

Version/Model Number

DYNJAAMASK02

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

-

Product Code

BSJ

Product Code Name

MASK, GAS, ANESTHETIC

Public Device Record Key

4446029f-8ac3-481e-b561-6443900df8b9

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-