Catalog Number

-

Brand Name

ThermaCor 1200 Infusion System

Version/Model Number

TSS-1200

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

K052055,K052055,K052055

Product Code

FRN

Product Code Name

Pump, infusion

Public Device Record Key

defedc74-c4a5-4716-b6f4-4be349e44886

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

July 15, 2016

Package DI Number

10857893006117

Quantity per Package

6

Contains DI Package

00857893006110

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box