Duns Number:188660844
Device Description: Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage4 Adjustable shelves. Upper Overall size 30”W x 26.5”D x 74.5”T. 17.59 Cubic ft. storage4 Adjustable shelves. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage.Temperature Range: 90-160 FAccuracy +/- 2 degrees F Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Temperature Range: 90-160 F Accuracy +/- 2 degrees F Digital control. Stainless steel doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Data loggerFoot levelersElectrical: 120V, 12 Amp, 50/60 Hz. 69kw/hr, 2356 btu/hr.
Catalog Number
FHCDWC36-TL-D
Brand Name
DUAL CHAMBER BLANKET/FLUID WARMER, SS DOOR
Version/Model Number
FHCDWC36-TL-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
eeb429dd-c87b-4ad5-9d54-21053571bbf8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 27, 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 |