Duns Number:036985604
Device Description: The STERIS Patient Warming System 3-inch TLT Pad Heated is used with the STERIS Patient Wa The STERIS Patient Warming System 3-inch TLT Pad Heated is used with the STERIS Patient Warming System.
Catalog Number
BF037
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
b769a6d9-07e8-4966-af68-774422144a4c
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 |