Duns Number:788744477
Device Description: The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended The Tablo Cartridge is a single use, disposable arterial and venous bloodline set intended to provide extracorporeal access during hemodialysis.
Catalog Number
-
Brand Name
Tablo(R) Cartridge
Version/Model Number
PN-0004221
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K140841,K190793,K140841,K190793
Product Code
FJK
Product Code Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Public Device Record Key
f0707176-fec2-40d5-83f8-83f26ec7c49c
Public Version Date
June 18, 2020
Public Version Number
4
DI Record Publish Date
January 11, 2019
Package DI Number
10850001011140
Quantity per Package
6
Contains DI Package
00850001011143
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |