Duns Number:188660844
Device Description: Overall size 30”W x 26.5”D x 36”T.8.63 Cubic ft. storageChamber I.D. 26”W x 23”D x 25”T. Overall size 30”W x 26.5”D x 36”T.8.63 Cubic ft. storageChamber I.D. 26”W x 23”D x 25”T. Temperature Range: 90-160 F Accuracy +/- 2 degrees F of set point2 Adjustable shelvesDigital controlGlass doorAudible and visual over-temp alarmData loggerLocking doorFoot levelersElectrical: 120V, 7.5 Amp, 50/60 Hz.35 kw/hr, 1195 btu/hrUL/CUL listedFDA Registered
Catalog Number
SWC243036-G-2B
Brand Name
WARMER, SINGLE CHAMBER
Version/Model Number
SWC243036-G-2B
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
0b84d171-f444-4a30-8fae-ee3ae2667ff6
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 |