Duns Number:094439676
Device Description: Interpleural Sump, Two Lumens, Round, Silicone, Rounded Closed Tip, With 3-Way Stop Cock, Interpleural Sump, Two Lumens, Round, Silicone, Rounded Closed Tip, With 3-Way Stop Cock, With ClotStop®
Catalog Number
-
Brand Name
Axiom® Interpleural Anesthesia Atraum™ With ClotStop®
Version/Model Number
112028AT
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
649f34c3-bce9-4ff9-aebb-1dbc2b379708
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 01, 2016
Package DI Number
M665112028AT3
Quantity per Package
6
Contains DI Package
M665112028AT1
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 |