Catalog Number

-

Brand Name

Cadwell Sleepmate

Version/Model Number

302544-200-0484

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

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

11effaa9-2df2-4919-ae02-9a6df9ef94e3

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

December 24, 2021

Package DI Number

10709078013697

Quantity per Package

50

Contains DI Package

00709078013690

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case