Duns Number:188660844
Device Description: Overall size 30”W x 26.5”D x 24.5”T.5.27 Cubic ft. storageChamber I.D. 26”W x 23”D x 15.25 Overall size 30”W x 26.5”D x 24.5”T.5.27 Cubic ft. storageChamber I.D. 26”W x 23”D x 15.25”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point1 Adjustable shelvesData logger Digital controlGlass doorAudible and visual over-temp alarm Keyed temperature lockFoot levelersElectrical: 120V, 7.5 Amp, 50/60 Hz.30kw/hr, 1024 btu/hr UL/CUL listedFDA Registered
Catalog Number
SKSWC24-TL-G-D
Brand Name
Counter Top Blanket/Fluid Warming Cabinet Outside Dimensions 30" W x 26.6"d x 24
Version/Model Number
SKSWC24-TL-G-D
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K080609
Product Code
LHC
Product Code Name
Warmer, Irrigation Solution
Public Device Record Key
3f4d5cd8-6253-4e94-ad9c-6c0a813721c5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 01, 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 | 456 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |