Duns Number:600267793
Device Description: Swabable Vial Adapter 20mm with Vented Spike – VF
Catalog Number
-
Brand Name
Swabable Vial Adapter with Vented Spike
Version/Model Number
8073012
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
K072511,K072511,K072511
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
bf319cd3-492f-493a-bcc1-b772ca257554
Public Version Date
August 09, 2019
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
27290108240027
Quantity per Package
4
Contains DI Package
17290108240020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 96 |