Duns Number:079375431
Device Description: ON-Q* Expansion Kits with SILVERSOAKER* Antimicrobial Catheter, 7.5 in (19 cm), Needle 8 i ON-Q* Expansion Kits with SILVERSOAKER* Antimicrobial Catheter, 7.5 in (19 cm), Needle 8 in. x 17 GA
Catalog Number
PM050-A
Brand Name
AVANOS
Version/Model Number
13541
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
K051401,K051401
Product Code
BSO
Product Code Name
CATHETER, CONDUCTION, ANESTHETIC
Public Device Record Key
2210844e-3061-4881-b9b1-321fd31eb947
Public Version Date
July 13, 2020
Public Version Number
1
DI Record Publish Date
July 03, 2020
Package DI Number
10193494135413
Quantity per Package
5
Contains DI Package
00193494135416
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 |