Duns Number:029646569
Device Description: CALCIUM CHLORIDE 3.1 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDE CALCIUM CHLORIDE 3.1 GRAM PACKETS - HEMODIALYSATE ADDITIVE - 0.25 mEq/L INCREASE WHEN ADDED TO 3.78 LITERS (1 GALLON) IN A 45X PROPORTIONING SYSTEM
Catalog Number
C31BX
Brand Name
Hemo-Dial
Version/Model Number
C315BX
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 24, 2022
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
K813388,K813388
Product Code
KPO
Product Code Name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Public Device Record Key
4c2b3616-4eb2-4f32-a26e-c84a22772a02
Public Version Date
February 25, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |