Duns Number:188660844
Device Description: Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60T.Cham Overall size 30”W x 20.5”D x 6 x 64.5”T. Overall size recessed. 30”W x 20.5”D x 60T.Chamber I.D. 26”W x 17”D x 51”T. 13.05 Cubic ft. storage. Digital control. 3 Adjustable shelves. Glass door Audible and visual over-temp alarm. Keyed emperature lock.Data loggerDoor lock4" baseAccuracy +/- 3 degrees F. Electrical: 120V, 7.5 Amp, 50/60 Hz. .46kw/hr, 1570 btu/hr. UL/CUL listed
Catalog Number
W2030MS-G-4B
Brand Name
SINGLE CHAMBER WARMING CABINET
Version/Model Number
W2030MS-G-4B
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
fbe85c56-c77c-47b2-9824-38062bf690b2
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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 |