Duns Number:079375431
Device Description: ON-Q* Pain Relief System, SOAKER* Catheter, NRFit™ Connector, 100 ml, 2 ml/hr, 5 in./12.5 ON-Q* Pain Relief System, SOAKER* Catheter, NRFit™ Connector, 100 ml, 2 ml/hr, 5 in./12.5 cm
Catalog Number
PS12502-N
Brand Name
Halyard
Version/Model Number
45048
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063530,K063530
Product Code
MEB
Product Code Name
PUMP, INFUSION, ELASTOMERIC
Public Device Record Key
116b9d03-b34a-45bd-a4f5-ec7dfe4d09d6
Public Version Date
November 16, 2018
Public Version Number
2
DI Record Publish Date
August 16, 2018
Package DI Number
30680651450488
Quantity per Package
5
Contains DI Package
10680651450484
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 269 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5221 |