Duns Number:037304144
Device Description: Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storageChamber I.D. 20”W x 17"D x 15.2 Overall size 24”W x 20.5”D x 24.5”T. 3.0 Cubic ft. storageChamber I.D. 20”W x 17"D x 15.25”T Temperature Range: 90-160 FAccuracy +/- 1 degrees F Digital control. Stainless steel door Audible and visual over-temp alarm. Keyed temperature lock for each chamber Foot levelersElectrical: 120V, 3.5 Amp, 50/60 Hz. .45kw/hr, 1537 btu/hr. UL/CUL listedFDA Registered
Catalog Number
FHCSWC1824-TL
Brand Name
COUNTER TOP BLANKET / FLUID WARMER Overall Size 24”W x 20.5”D x 24.5”T
Version/Model Number
FHCSWC1824-TL
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
-
Product Code
LHC
Product Code Name
Warmer, Irrigation Solution
Public Device Record Key
439585d8-a60e-4de1-96d9-a88b5dfe0429
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 11, 2017
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 | 287 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |