Duns Number:078375583
Device Description: Warming cabinet, 2 compartment, 3 adj shelves, independent digital cntrls w/lockout & USB Warming cabinet, 2 compartment, 3 adj shelves, independent digital cntrls w/lockout & USB data retri
Catalog Number
-
Brand Name
Skytron warming cabinet
Version/Model Number
W2-753027
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
-
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
Public Device Record Key
84d4f0f8-2d09-436a-b155-83908cbe6816
Public Version Date
May 08, 2020
Public Version Number
1
DI Record Publish Date
April 30, 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 | 747 |
2 | A medical device with a moderate to high risk that requires special controls. | 265 |