Duns Number:958291411
Device Description: NaturaLyte Dry Pack Sodium Bicarbonate, Carton
Catalog Number
08-4400-1
Brand Name
NaturaLyte
Version/Model Number
08-4400-1
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
-
Product Code
KPO
Product Code Name
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Public Device Record Key
98450890-0b14-486a-9807-0b91a479eb3e
Public Version Date
November 01, 2021
Public Version Number
5
DI Record Publish Date
October 02, 2015
Package DI Number
10840861101969
Quantity per Package
12
Contains DI Package
00840861101962
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 65 |