Duns Number:595138793
Device Description: Interface cable of 60" cable length with a round shape, 4-pins monitor connector.
Catalog Number
684253
Brand Name
TC-HEART LUNG 60IN HEART LUNG
Version/Model Number
684253
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
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
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
fc5407b3-fdcf-4dc8-b007-898db959adef
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
50886333642538
Quantity per Package
1
Contains DI Package
00886333642533
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Zip Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |