Duns Number:080593067
Device Description: CENTRAL VENOUS CATETHER TRIPLE LUMEN 7 Fr X 15 CM
Catalog Number
M209
Brand Name
MEDADV
Version/Model Number
M209
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
K102833,K102833
Product Code
MPB
Product Code Name
Catheter, Hemodialysis, Non-Implanted
Public Device Record Key
00203799-46ce-458e-837b-259049f1f43d
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
April 10, 2018
Package DI Number
10819667020255
Quantity per Package
10
Contains DI Package
00819667020258
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |