Duns Number:965879187
Device Description: HotDog Temperature Management Controller - Single Port
Catalog Number
WC71
Brand Name
HotDog Temperature Management System
Version/Model Number
WC71
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"
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
K201779
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
d90c5a93-ec1c-4920-b3ff-b311d6555f1e
Public Version Date
May 25, 2022
Public Version Number
1
DI Record Publish Date
May 17, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |