Catalog Number

1515

Brand Name

Rescuer Disposable Resuscitation Cushion Mask (#2 Infant)

Version/Model Number

1515

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

5ae1c649-b627-41f4-80e3-8d1ee0b8998d

Public Version Date

November 05, 2018

Public Version Number

1

DI Record Publish Date

October 03, 2018

Package DI Number

B00215156

Quantity per Package

30

Contains DI Package

B00215150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag