Duns Number:038000253
Device Description: 10F X 52CM ARTERIAL10F X 52CM AR BIO-FLEX®TESIO®CATHETE W/CUFFW/CUFF (CUFF 18.2CM FROM TIP 10F X 52CM ARTERIAL10F X 52CM AR BIO-FLEX®TESIO®CATHETE W/CUFFW/CUFF (CUFF 18.2CM FROM TIP)(CUFF 18.2
Catalog Number
DBFS18
Brand Name
BIO-FLEX®TESIO®
Version/Model Number
DBFS18
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 12, 2021
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
MSD
Product Code Name
Catheter, hemodialysis, implanted
Public Device Record Key
31b5108c-7548-48ac-a5c6-a3c315a805e3
Public Version Date
September 20, 2021
Public Version Number
3
DI Record Publish Date
August 31, 2019
Package DI Number
50884908145941
Quantity per Package
10
Contains DI Package
00884908145946
Package Discontinue Date
July 12, 2021
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |