Duns Number:186855925
Device Description: The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lav The IPH Procedure kit contains the sterile components needed to perform a hyperthermic lavage. The disposable items are intended for single use. The kit contains sterile tubing, inflow and outflow cannulae, temperature monitoring probes, heat exchanger and reservoir.
Catalog Number
IPH-2000
Brand Name
ThermoChem
Version/Model Number
IPH Procedure Kit
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
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
MLW
Product Code Name
Warmer, Peritoneal Dialysate
Public Device Record Key
0e10fc92-abc8-4d43-84cb-f5ee0d495110
Public Version Date
June 14, 2022
Public Version Number
1
DI Record Publish Date
June 06, 2022
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 |