Duns Number:658863238
Device Description: Canister for VT• One - 150ml luer lock
Catalog Number
-
Brand Name
NA
Version/Model Number
S1004-6030
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
7c39d5bc-9c0c-4a32-a28f-c3ceee606e02
Public Version Date
March 24, 2021
Public Version Number
1
DI Record Publish Date
March 16, 2021
Package DI Number
04719873695676
Quantity per Package
5
Contains DI Package
04719873695669
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 144 |