Duns Number:308951313
Device Description: The catheter is designed for percutaneous biliary drainage. The operator can use different The catheter is designed for percutaneous biliary drainage. The operator can use different drainage sets according to the type of accumulated fluid and place of accumulation. These kits are classified according to the catheter size (8F~14F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D140 or D145 (with or without locking pigtail).
Catalog Number
D14014040
Brand Name
M-Drain
Version/Model Number
D14014040
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
K033862,K033862
Product Code
FGE
Product Code Name
Catheter, Biliary, Diagnostic
Public Device Record Key
f3d44d3d-9339-4c3f-8446-8348f15056e9
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
05711055000451
Quantity per Package
5
Contains DI Package
15711055000458
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |