Catalog Number

T5125ST

Brand Name

DeRoyal

Version/Model Number

T5125ST

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

ILO

Product Code Name

Pack, hot or cold, water circulating

Public Device Record Key

c11833ce-8115-44b3-81d0-96071940025d

Public Version Date

November 18, 2019

Public Version Number

1

DI Record Publish Date

November 09, 2019

Package DI Number

50749756350018

Quantity per Package

200

Contains DI Package

00749756350013

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case