Duns Number:531408342
Device Description: Replacement Drainage Bag, 500 ml, with female Luer-lock connector, a suspension hook, and Replacement Drainage Bag, 500 ml, with female Luer-lock connector, a suspension hook, and a hydrophobic filter.
Catalog Number
910116A
Brand Name
External Drainage Set
Version/Model Number
910116A
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
a04760d3-5269-4ac0-9a2d-7a752ec5967d
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
October 01, 2015
Package DI Number
30381780035545
Quantity per Package
6
Contains DI Package
10381780035541
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 |