Duns Number:079219081
Device Description: Bbraun 7" MicroBore Catheter Extension set with InVision-Plus
Catalog Number
-
Brand Name
Rymed
Version/Model Number
460201
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
K991653,K991653,K991653
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
6ce79341-563b-4255-b489-ccbe0493f259
Public Version Date
May 19, 2020
Public Version Number
3
DI Record Publish Date
April 25, 2018
Package DI Number
20817903010180
Quantity per Package
4
Contains DI Package
10817903010183
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 57 |