Duns Number:120818216
Device Description: PREMICATH 28 G (1 FR) 20 CM CATHETER WITH STYLET AND SPLIT CANNULA INTRODUCER
Catalog Number
1261.205A
Brand Name
VYGON
Version/Model Number
1261.205A
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
K041468,K041468
Product Code
LJS
Product Code Name
Catheter, intravascular, therapeutic, long-term greater than 30 days
Public Device Record Key
956e7f58-efde-4b92-a6f1-0b6f3abaee2d
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
March 19, 2020
Package DI Number
30849884002288
Quantity per Package
10
Contains DI Package
00849884002287
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 124 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 833 |