Catalog Number

CUCM005L

Brand Name

Sunset Healthcare Solutions Deluxe Full Face Mask Replacement Cushion - Large

Version/Model Number

CUCM005L

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

-

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

K063268,K063268

Product Code

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Public Device Record Key

6aababc5-a63d-4b5e-a041-c2df0beba00f

Public Version Date

February 26, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10848530040434

Quantity per Package

50

Contains DI Package

00848530040437

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton