Duns Number:094651270
Device Description: SET W/ LUER LOCKING CONNECTIONS AND HEATING COIL, Peritoneal Dialysis Set for Neonates
Catalog Number
4000527
Brand Name
DIALY-NATE
Version/Model Number
Set
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
FKO
Product Code Name
Catheter, Peritoneal Dialysis, Single Use
Public Device Record Key
8b42f48c-3a83-48fe-8eb2-90cee6cf9ba2
Public Version Date
December 18, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |