Duns Number:094439676
Device Description: Closed Wound Drain, Flat, Silicone, With Reservoir
Catalog Number
-
Brand Name
Axiom® CWV
Version/Model Number
3601
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K790654,K790654,K790654
Product Code
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
f64ed9a4-baef-4bc2-93a9-fac47740d1ab
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2018
Package DI Number
M66536013
Quantity per Package
6
Contains DI Package
M66536011
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 187 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |