Catalog Number

1118999

Brand Name

Contour Deluxe

Version/Model Number

Contour Deluxe Mask and Headgear, SPU, Small, INTL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2099

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991648,K991648,K991648

Product Code

BZD

Product Code Name

VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Public Device Record Key

385357be-a086-451c-a786-ea4d7787b2fe

Public Version Date

January 25, 2021

Public Version Number

4

DI Record Publish Date

October 29, 2015

Package DI Number

40606959000733

Quantity per Package

10

Contains DI Package

00606959000735

Package Discontinue Date

December 31, 1999

Package Status

Not in Commercial Distribution

Package Type

EACH