Duns Number:006261481
Device Description: CUSTOM PACK TL4H65R TL BIO-PUMP
Catalog Number
-
Brand Name
Custom Perfusion System
Version/Model Number
TL4H65R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 17, 2015
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K973011
Product Code
KFM
Product Code Name
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Public Device Record Key
fa0c202f-5e59-4095-a512-f32c081ed175
Public Version Date
May 08, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2014
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |