Catalog Number

00315-03Z -No C

Brand Name

Halyard

Version/Model Number

94727

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

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

67278737-f23f-4c8e-81c5-f173f179e610

Public Version Date

October 17, 2018

Public Version Number

3

DI Record Publish Date

September 30, 2016

Package DI Number

30680651947278

Quantity per Package

5

Contains DI Package

10680651947274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS