Duns Number:021249224
Device Description: The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Pat The Model 2002 Controller regulates the temperature of and the power to the Model 4003 Patient Warming Mattress. It is powered by Model 100026-PA AC Power Adapter or Model 100026 Battery. The Controller monitors current, zone power, the temperature sensors, and detects faults in the mattress or system.
Catalog Number
-
Brand Name
Controller
Version/Model Number
2002
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
K132454
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
28b0f308-e42c-4705-b536-022463d94f00
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 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. | 10 |