Duns Number:079375431
Device Description: ON-Q* Pain Relief System with SELECT-A-FLOW* and Bolus, 400 ml, 2-14 ml/hr + 3 ml bolus/20 ON-Q* Pain Relief System with SELECT-A-FLOW* and Bolus, 400 ml, 2-14 ml/hr + 3 ml bolus/20 min
Catalog Number
CB006C
Brand Name
Halyard
Version/Model Number
46857
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K181360,K181360
Product Code
MEB
Product Code Name
PUMP, INFUSION, ELASTOMERIC
Public Device Record Key
e27b299c-8db6-4b1a-b675-cef2b6589bb8
Public Version Date
April 10, 2019
Public Version Number
1
DI Record Publish Date
April 02, 2019
Package DI Number
30680651468575
Quantity per Package
5
Contains DI Package
10680651468571
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 |