Catalog Number

167500

Brand Name

Mask, Face, Neonate, w/o Valve

Version/Model Number

Mask, Face, Neonate, w/o Valve - 167500

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

BYG

Product Code Name

Mask, Oxygen

Public Device Record Key

d1bb6086-8201-4885-b8e0-36011b1e26d5

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Package DI Number

00817081025996

Quantity per Package

20

Contains DI Package

00817081025989

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-