Duns Number:343689704
Device Description: H.E.L.P. HEPARIN ADSORBER (US)
Catalog Number
7210933
Brand Name
B.BRAUN
Version/Model Number
7210933
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 12, 2020
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
-
Product Code
MMY
Product Code Name
LIPOPROTEIN, LOW DENSITY, REMOVAL
Public Device Record Key
0b764886-e732-45c2-ac81-ed4033991f23
Public Version Date
April 24, 2020
Public Version Number
6
DI Record Publish Date
January 18, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |