Duns Number:942139841
Device Description: 230V, 50/60Hz HTAIR HoverTech Air Supply
Catalog Number
HTAIR2356
Brand Name
HoverTech Air Supply
Version/Model Number
HTAIR2356
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
FNG
Product Code Name
LIFT, PATIENT, AC-POWERED
Public Device Record Key
1b74f7e8-1f76-4438-9a21-f5f830d89063
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 30, 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. | 72 |