Duns Number:188660844
Device Description: Overall size 30”W x 26.5”D x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft Overall size 30”W x 26.5”D x 74.5”T. Upper Chamber I.D. 26”W x 23”D x 25”T 8.63 Cubic ft. storage.Lower chamber I.D. 26 “W x 23”D x 26”T 8.96 Cubic ft. storage. Digital control. 4 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Keyed temperature lock for each chamber Foot levelers.Accuracy +/- 2 degrees F (upper chamber). Accuracy +/- 2 degrees F (lower chamber). Electrical: 220V
Catalog Number
FHCDWC36-TL-220
Brand Name
DUAL CHAMBER BLANKET/FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T
Version/Model Number
FHCDWC36-TL-220
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
ad318096-0ff1-4ff5-8a60-de4d3f9e8089
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 |