Duns Number:531408342
Device Description: The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector The Integral Drainage Set (IDS) consists of a one-piece assembly (male Luer-lock connector; small diameter drainage inlet tube with attached clamp, check valve, and silicone band; graduated bag with hydrophobic vent filter, drip chamber, suspension string with adjustable clip; large diameter drainage collector; outlet tube with clamp, watertight cap and silicone band); a 360° three-way stopcock with Luer-lock connectors; two stopcock protection boxes.
Catalog Number
910410B
Brand Name
Integral Drainage Set
Version/Model Number
910410B
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 2018
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
K924600
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
a4aeed47-ed38-4aa6-957a-0acc4c3658f8
Public Version Date
July 13, 2018
Public Version Number
5
DI Record Publish Date
October 01, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |