Duns Number:788744477
Device Description: The Tablo System is indicated for use in patients with acute and/or chronic renal failure, The Tablo System is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute orchronic care facility.
Catalog Number
PN-0003000
Brand Name
Tablo(R) Hemodialysis System
Version/Model Number
PN-0003000
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
-
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
FIP
Product Code Name
Subsystem, Water Purification
Public Device Record Key
b6064c95-6f58-4067-a71a-60e9c35946a8
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
January 11, 2019
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 9 |