Catalog Number

550244

Brand Name

Hopkins Medical Products®

Version/Model Number

550244

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"

-

For Single-Use

Yes

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

K970688

Product Code

KGB

Product Code Name

MASK, OXYGEN, NON-REBREATHING

Public Device Record Key

367b0f43-00f9-4631-955f-1e15dfa4bf74

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-