Duns Number:188660844
Device Description: Overall size 30”W x 26.5”D x 74.5”T.21 Cubic ft. storageChamber I.D. 26”W x 23”D x 61”T. Overall size 30”W x 26.5”D x 74.5”T.21 Cubic ft. storageChamber I.D. 26”W x 23”D x 61”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set pointData logger 2 Adjustable shelves1 Fixed shelfDigital controlGlass doorAudible and visual over-temp alarmFoot levelersElectrical: 120V, 7.5 Amp, 50/60 Hz.53 kw/hr, 1810 btu/hrUL/CUL listedFDA Registered
Catalog Number
FHCSWC72-TL-G-D
Brand Name
SINGLE CHAMBER BLANKET / FLUID WARMER Overall Size 30”W x 26.5”D x 74.5”T
Version/Model Number
FHCSWC72-TL-G-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
88ebec1e-8a4e-423b-b0f2-0c35d59a8cb5
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 |