Duns Number:066232067
Device Description: Heating Element Only
Catalog Number
AIH102
Brand Name
HEATING ELEMENT 350W-120V
Version/Model Number
AIH102
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
FMT
Product Code Name
Warmer, Infant Radiant
Public Device Record Key
8a86e08b-a0f9-45b4-9642-3c324b3d571f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 09, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 131 |