Duns Number:071459661
Device Description: The Pintler Patient Warming System a thermal regulating reusable operating room pad and a The Pintler Patient Warming System a thermal regulating reusable operating room pad and a power control unit . The operating room pad utilizes a low voltage heating element and warms patients with conductive warming technology. The system aids in the function of assisting in maintaining patient warming during perioperative experience for pediatric and adult patients and would be indicated for use in any condition where patient warming is desired
Catalog Number
PPWS001
Brand Name
Pintler Patient Warming System
Version/Model Number
PPWS001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K113705
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
d0f276c3-02a1-41c6-98ef-a57775686c71
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 11, 2019
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. | 1 |