Duns Number:343689704
Device Description: EMPTY BAGS FOR DIALYSATE FUTURA (US)
Catalog Number
7210930
Brand Name
B.BRAUN
Version/Model Number
7210930
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
P940016,P940016,P940016,P940016,P940016,P940016
Product Code
MMY
Product Code Name
LIPOPROTEIN, LOW DENSITY, REMOVAL
Public Device Record Key
f1bf4846-0173-40a7-8146-d134ff23a5d5
Public Version Date
April 29, 2019
Public Version Number
4
DI Record Publish Date
January 18, 2017
Package DI Number
04046963711184
Quantity per Package
25
Contains DI Package
04046964249679
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 69 |
3 | A medical device with high risk that requires premarket approval | 1 |