Duns Number:079375431
Device Description: ON-Q* Fixed Flow Pump Kits With ON-Q* Soaker* Catheter
Catalog Number
P400X8-N
Brand Name
AVANOS
Version/Model Number
44946
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
5e9a7f1d-cb13-4608-98ff-94355b6caa46
Public Version Date
June 17, 2020
Public Version Number
2
DI Record Publish Date
May 07, 2020
Package DI Number
10193494449466
Quantity per Package
5
Contains DI Package
00193494449469
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 |