Duns Number:188660844
Device Description: Overall size 18”W x 15.5”D x 22”T. 1.4 Cubic ft. storageChamber I.D. 14”W x 13"D x 13”T Overall size 18”W x 15.5”D x 22”T. 1.4 Cubic ft. storageChamber I.D. 14”W x 13"D x 13”T Temperature Range: 90-135 FAccuracy +/- 1 degrees F Digital control. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data LoggerLocking doorFoot levelersElectrical: 120V, 3.5 Amp, 50/60 Hz. .39kw/hr, 1332 btu/hr. UL/CUL listedFDA Registered
Catalog Number
SWC151822-NB
Brand Name
COUNTER TOP/WALL MOUNT SINGLE CHAMBER BLANKET/FLUID WARMER
Version/Model Number
SWC151822-NB
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
8106fe86-ab9a-49db-88eb-a6d3c810e96e
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 |