Duns Number:830432451
Device Description: Circuit tubing, 18" smooth bore, pack of 10
Catalog Number
09532D
Brand Name
Vela
Version/Model Number
09532D
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"
Yes
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
K093094,K093094
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
a32aa397-fd6b-4246-9c0e-0cb7275cd32c
Public Version Date
October 24, 2022
Public Version Number
5
DI Record Publish Date
June 23, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |