Duns Number:134139174
Device Description: Single Stage Venous Return Cannula
Catalog Number
TFM026L
Brand Name
Thin-Flex Single Stage Malleable Venous Drainage Cannula
Version/Model Number
TFM026L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2017
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120072,K120072
Product Code
DWF
Product Code Name
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Public Device Record Key
11edb7f9-ee34-423d-8d00-605dc8e9f8f5
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
50690103154042
Quantity per Package
10
Contains DI Package
00690103154047
Package Discontinue Date
December 31, 2017
Package Status
Not in Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |