Duns Number:938289980
Device Description: A collection of sterile devices including tubing and typically clamps, filters, connectors
Catalog Number
H-7915
Brand Name
SACRED HEART AORTIC LINE, FL. EXTRACORPOREAL TUBE PACK
Version/Model Number
H-7915
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTM
Product Code Name
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Public Device Record Key
aada79ef-b1a2-475d-b5e4-78c182a2892b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 06, 2015
Package DI Number
B066H79153
Quantity per Package
50
Contains DI Package
B066H79150
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |