Duns Number:094439676
Device Description: Sump Drain, Two Lumens, Silicone, Large Eye, With Suture Ring
Catalog Number
-
Brand Name
Axiom® Uni-Sump
Version/Model Number
111178SR
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
K771048,K771048,K771048
Product Code
FEG
Product Code Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Public Device Record Key
fd9bfd2e-7037-4184-85de-606df68163ac
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M665111178SR3
Quantity per Package
10
Contains DI Package
M665111178SR1
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 |