Duns Number:531408342
Device Description: The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and The External Drainage Set (EDS) consists of: an extension tubing line with a T fitting and a four-way stopcock; a one-piece drainage tube assembly, including a patient line with a T fitting, a tubing, an antireflux valve, a 75 ml cylinder and a drainage tubing; a drainage bag with female luer lock connector, a suspension hook and a hydrophobic filter; a 350 mm H2O drainage pressure scale.
Catalog Number
910110A
Brand Name
External Drainage Set
Version/Model Number
910110A
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
-
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
bdcfb17d-0335-4d39-b392-ef03f9afca3a
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
October 01, 2015
Package DI Number
30381780035507
Quantity per Package
6
Contains DI Package
10381780035503
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |