Duns Number:008312423
Device Description: TURBINE ASSY, 12" DEEP TANK, 220V
Catalog Number
TA12M220V
Brand Name
Whirlpool Turbine
Version/Model Number
TA-12-M-220V
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
ILJ
Product Code Name
Bath, Hydro-Massage
Public Device Record Key
2e77fc3b-cce6-40d1-94db-153cf3434b5d
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 12, 2019
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 | 157 |
2 | A medical device with a moderate to high risk that requires special controls. | 296 |