Duns Number:308951313
Device Description: The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, The catheter is designed for percutaneous drainage of abscess fluid, nephrostomy, urinary, pleural empyemas, lung abscesses, and mediastinal collections. 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 (5F~16F pertaining to various fluid viscosity) and according to the position of the accumulation. The operator can choose either D105 without locking pigtail or D110 with locking pigtail.
Catalog Number
D11006035S
Brand Name
M-Drain
Version/Model Number
D11006035S
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
30c4cef6-2b7e-4fec-b09a-b2e956e7b471
Public Version Date
September 09, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
05711055002721
Quantity per Package
5
Contains DI Package
15711055002728
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 |