Catalog Number

-

Brand Name

ThermaCor 1200 Infusion System

Version/Model Number

RCAU-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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K052055

Product Code

FRN

Product Code Name

Pump, infusion

Public Device Record Key

aae038ff-8c47-4df8-bf48-8c3402950651

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

November 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-