Catalog Number

8700M

Brand Name

Rescuer 8700 Large Deluxe CPAP Mask Only

Version/Model Number

8700M

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

K122610,K122610

Product Code

BYE

Product Code Name

Attachment, Breathing, Positive End Expiratory Pressure

Public Device Record Key

f1bd5a06-57d9-401e-bb14-4c7daed7363e

Public Version Date

November 02, 2018

Public Version Number

1

DI Record Publish Date

October 02, 2018

Package DI Number

B0028700M6

Quantity per Package

30

Contains DI Package

B0028700M0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton