Duns Number:343689704
Device Description: Solcart B® Bicarbonate Cartridge 1100 grams
Catalog Number
805
Brand Name
Sol-Cart B®
Version/Model Number
805
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
K102194,K102194
Product Code
KPO
Product Code Name
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Public Device Record Key
cf1152c2-6671-4249-bae3-5263410faa1f
Public Version Date
July 07, 2020
Public Version Number
9
DI Record Publish Date
August 09, 2015
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 |