Duns Number:600267793
Device Description: Mix2Vial™ 20/20mm w/15µm Large Filter TG
Catalog Number
-
Brand Name
Mix2Vial Transfer Device
Version/Model Number
8074046
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
K031861,K031861,K031861
Product Code
LHI
Product Code Name
Set, I.V. Fluid Transfer
Public Device Record Key
19d41b6e-8141-4d98-bf85-5b3deec0328c
Public Version Date
August 09, 2019
Public Version Number
6
DI Record Publish Date
May 01, 2016
Package DI Number
27290108240997
Quantity per Package
4
Contains DI Package
17290108240990
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 |