Catalog Number

CLM 0116

Brand Name

Cocoon

Version/Model Number

CLM 0116

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

DWJ

Product Code Name

System, Thermal Regulating

Public Device Record Key

769ffc0e-df23-42f3-a145-d3106cfb7d71

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

February 26, 2021

Package DI Number

09332017000195

Quantity per Package

10

Contains DI Package

09332017000119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton