Duns Number:338664915
Device Description: The drainage system is composed of a silicone reservoir equipped with an anti-backflow val The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors for connection to the drainage tube. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full.
Catalog Number
10400
Brand Name
Silicone Reservoir 100ml
Version/Model Number
10400
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"
-
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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
598ed122-9dd3-449a-8a45-b89ca851b55f
Public Version Date
May 05, 2021
Public Version Number
2
DI Record Publish Date
October 21, 2020
Package DI Number
18034139290574
Quantity per Package
10
Contains DI Package
08034139290577
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 | 105 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |