Duns Number:965879187
Device Description: Labeled: Hot Dog Patient Warming System Multifunction Controller Refurbished Equipment WC5 Labeled: Hot Dog Patient Warming System Multifunction Controller Refurbished Equipment WC52R
Catalog Number
WC52R
Brand Name
Hot Dog Patient Warming System Multifunction Controller Refurbished Equipment
Version/Model Number
WC52R
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
K094056
Product Code
DWJ
Product Code Name
System, Thermal Regulating
Public Device Record Key
a11b2ccc-cc3c-416b-add9-9d2e9dc42624
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 28, 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 |
|---|---|---|
| 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 |