Duns Number:037304144
Device Description: Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 17”D x 51”T Overall size 30”W x 20.5”D x 64.5”T.13.05 Cubic ft. storageChamber I.D. 26”W x 17”D x 51”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point3 Adjustable shelvesDigital controlGlass doorAudible and visual over-temp alarmFoot levelersElectrical: 120V, 7.5 Amp, 50/60 Hz.46 kw/hr, 1570 btu/hrUL/CUL listedFDA Registered
Catalog Number
FHCSWC60-TL-G
Brand Name
SINGLE CHAMBER BLANKET/FLUID WARMER Overall Size Freestanding 30”W x 20.5”D x 64
Version/Model Number
FHCSWC60-TL-G
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"
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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
80e9a104-4123-4671-b1e5-2367c6917d78
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 12, 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 |