Duns Number:007941230
Device Description: Decanter Bag For Aseptic Transfer Of Fluids From Flexible Containers Acrylonitrile-Butadie Decanter Bag For Aseptic Transfer Of Fluids From Flexible Containers Acrylonitrile-Butadiene-Styrene Plastic Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
BD10102
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
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
K852777,K852777
Product Code
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
244cd977-b6ca-4f6f-83b8-f98179d69aeb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632107632
Quantity per Package
50
Contains DI Package
10885632107634
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |