Duns Number:315578914
Catalog Number
-
Brand Name
Ventstar Coax 230
Version/Model Number
MP03376
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
Yes
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
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
28ddc587-0d29-491b-acc9-84ba514fb391
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
November 19, 2018
Package DI Number
04048675545620
Quantity per Package
20
Contains DI Package
04048675545613
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 220 |
2 | A medical device with a moderate to high risk that requires special controls. | 160 |