Duns Number:094439676
Device Description: Interpleural Sump, Two Lumens, Round, Silicone, Rounded Closed Tip, With 3-Way Stop Cock
Catalog Number
-
Brand Name
Axiom® Interpleural Anesthesia
Version/Model Number
112028
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
K971851,K971851,K971851
Product Code
BSO
Product Code Name
Catheter, Conduction, Anesthetic
Public Device Record Key
65afca3e-16ec-43e7-a387-c253b6979aa5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
M6651120283
Quantity per Package
6
Contains DI Package
M6651120281
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 |