Duns Number:002348191
Device Description: Large Volume Abdominal Paracentesis Kit
Catalog Number
AK-00376
Brand Name
ARROW
Version/Model Number
IPN036363
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K874063,K874063
Product Code
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
603c0761-6962-4c73-af42-57810c8d8eee
Public Version Date
January 20, 2021
Public Version Number
5
DI Record Publish Date
December 05, 2017
Package DI Number
60801902120108
Quantity per Package
6
Contains DI Package
50801902120101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |