Duns Number:186855925
Device Description: The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile s The ThermoChem HT is a hyperthermia device that continuously circulates a heated sterile solution throughout the patients abdomen. The device accurately raises temperature to a predetermined target selected by the physician.
Catalog Number
HT-2000
Brand Name
ThermoChem
Version/Model Number
HT-2000
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
-
Product Code
MLW
Product Code Name
Warmer, Peritoneal Dialysate
Public Device Record Key
ed626c6a-c101-4fca-ad79-d1daefb82113
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |