Catalog Number

8001-064-037

Brand Name

Insulated Clik Tite

Version/Model Number

8001-064-037

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

-

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

K152266

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

4268a1f5-a9ed-4aa3-b5e6-dcb7044df1b8

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

December 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-