Duns Number:036985604
Device Description: The STERIS Patient Warming System (PWS) uses a heated surgical table pad and optional over The STERIS Patient Warming System (PWS) uses a heated surgical table pad and optional overbody blanket immediately upon transfer to the surgical table to provide heat to the patient before, during or after procedures in the Operating Room.
Catalog Number
BF030
Brand Name
STERIS
Version/Model Number
Patient Warming System
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
DWJ
Product Code Name
System, thermal regulating
Public Device Record Key
531c85e4-38c2-47ac-957a-71e517d93961
Public Version Date
November 24, 2020
Public Version Number
2
DI Record Publish Date
August 31, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |