Duns Number:316150549
Device Description: The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 g The Adsorba 150C hemoperfusion cartridge is a steam sterilized device which contains 150 grams of cellulose-coated activated charcoal. The device is filled with physiological saline solution prior to sterilization.
Catalog Number
101097
Brand Name
Adsorba Hemoperfusion cartridge
Version/Model Number
150C
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
K873643,K873643
Product Code
FLD
Product Code Name
Apparatus, hemoperfusion, sorbent
Public Device Record Key
7c025cd7-2ec3-44bc-9032-64225f22657a
Public Version Date
October 19, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
37332414015481
Quantity per Package
6
Contains DI Package
07332414015480
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |