Duns Number:812560399
Device Description: The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment usin The Gambro Cartridge Blood Set is intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery System from Rev. SW 3.40. The Low Weight - Low Volume model is used when a low extracorporeal blood volume is recommended.
Catalog Number
114435
Brand Name
Cartridge Blood Set
Version/Model Number
114435
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
K100364,K100364
Product Code
FJK
Product Code Name
SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
Public Device Record Key
f9d5b312-8625-4bb9-8f31-bf4939ee75a2
Public Version Date
October 11, 2022
Public Version Number
5
DI Record Publish Date
October 23, 2015
Package DI Number
37332414112401
Quantity per Package
15
Contains DI Package
07332414112400
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. | 9 |