Duns Number:948683941
Device Description: LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment LifeSPARC Blood Pump, TandemLung Oxygenator, 31 Fr ProtekDuo Veno-Venous Rapid Deployment cannula and accessories
Catalog Number
-
Brand Name
TandemLung LifeSPARC
Version/Model Number
5830-3631
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
-
Product Code
DRE
Product Code Name
Dilator, Vessel, For Percutaneous Catheterization
Public Device Record Key
3c31bd48-fc78-4b76-b6c5-9b3156e0a1ef
Public Version Date
June 08, 2020
Public Version Number
1
DI Record Publish Date
May 29, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |