Duns Number:079628327
Device Description: Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of woo Insta/Vent Mobile Cabinet. (For Insta/Vent Lead Shield). Mobile Cabinet constructed of wood and almond color formica. Includes sliding shelf that locks lead shield in place and brings it close to a patient, decay leaded area, storage area for supplies, swivel casters with front brakes. Oxygen tank is optional.
Catalog Number
-
Brand Name
Insta/Vent
Version/Model Number
IV-603
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
K960397
Product Code
IYT
Product Code Name
System, Rebreathing, Radionuclide
Public Device Record Key
fe67e772-d665-43d2-9e77-0e6b892865ea
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 |