Duns Number:038000253
Device Description: 10F Bio-Flex®Tesio® CATHETERS (LEFT) (ARTERIAL CUFF - 27CM FROM TIP) (VENOUS CUFF - 30CM F 10F Bio-Flex®Tesio® CATHETERS (LEFT) (ARTERIAL CUFF - 27CM FROM TIP) (VENOUS CUFF - 30CM FROM TIP)
Catalog Number
-
Brand Name
Bio-Flex®Tesio® Catheters
Version/Model Number
AAC11002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 29, 2020
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
74219877-7d3b-4c8d-819d-0bb08db43cb1
Public Version Date
June 22, 2021
Public Version Number
6
DI Record Publish Date
November 17, 2015
Package DI Number
50884908000509
Quantity per Package
5
Contains DI Package
00884908000504
Package Discontinue Date
September 29, 2020
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 |