Duns Number:079628327
Device Description: Mobile Cabinet w/Swing Arm (for Aero/Vent Jr., Aero/Vent Max, and Aero/Vent Plus Lead Shie Mobile Cabinet w/Swing Arm (for Aero/Vent Jr., Aero/Vent Max, and Aero/Vent Plus Lead Shields) - Metal. Powder coated steel, almond color cabinet includes locking decay leaded area, storage area for supplies, swivel casters with front brakes, rubber bumpers on all corners and a rotating swing arm that locks the shield in place and brings it close to a patient. Oxygen tank holder is optional.
Catalog Number
-
Brand Name
Aero/Vent Plus, Aero/Vent Max, Aero/Vent Jr.
Version/Model Number
UV-204-SA
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K865107
Product Code
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
76b21864-3314-4505-a42a-ee45bb7b3f0f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 09, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |