Duns Number:192559557
Device Description: ASPIRATION FLUSH ADAPTER – LARGE BORE SYSTEM
Catalog Number
AFA-LB
Brand Name
Aspiration and Flush Assembly
Version/Model Number
AFA-LB
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GBO
Product Code Name
Catheter, Nephrostomy, General & Plastic Surgery
Public Device Record Key
5b6f0f30-d32c-476e-8c77-1e8987b2d4c6
Public Version Date
May 27, 2022
Public Version Number
1
DI Record Publish Date
May 19, 2022
Package DI Number
10817640020100
Quantity per Package
5
Contains DI Package
00817640020103
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 179 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| U | Unclassified | 24 |