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, and a drainage tube. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. 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. The drainage system is a sterile and single-use device.
Catalog Number
10401
Brand Name
100 ml Bulb and JP Flat 3/4 fenestration 3 x 7 mm
Version/Model Number
10401
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
a5a711ba-f383-4936-8c44-2f6e42731fda
Public Version Date
May 05, 2021
Public Version Number
3
DI Record Publish Date
October 21, 2020
Package DI Number
18034139290581
Quantity per Package
10
Contains DI Package
08034139290584
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Boc
| 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 |