Duns Number:079375431
Device Description: ON-Q* Expansion Kits, SOAKER* Catheter, NRFit™ Connector, 2.5 in (6.5 cm), Needle 3.25 in. ON-Q* Expansion Kits, SOAKER* Catheter, NRFit™ Connector, 2.5 in (6.5 cm), Needle 3.25 in. x 17 GA
Catalog Number
PM010-N
Brand Name
Halyard
Version/Model Number
45161
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
-
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
318993de-7596-40ec-b3f3-1caa4de8cd3e
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
August 16, 2018
Package DI Number
30680651451614
Quantity per Package
5
Contains DI Package
10680651451610
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 |