Duns Number:042823948
Device Description: Royal Flush Plus High-Flow Catheter
Catalog Number
HN6.0-38-100-P-8S-GENSINI-01
Brand Name
Royal Flush
Version/Model Number
G58555
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180054,K180054
Product Code
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
8f39faf3-f226-4691-807d-fe26915fce8b
Public Version Date
November 20, 2020
Public Version Number
1
DI Record Publish Date
November 12, 2020
Package DI Number
10827002585550
Quantity per Package
5
Contains DI Package
00827002585553
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Each
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |