Duns Number:788744477
Device Description: Tablo X Cartridge with Needleless Infusion Ports
Catalog Number
PN-0004220
Brand Name
Tablo(R) Cartridge
Version/Model Number
PN-0005643
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
K210782,K210782
Product Code
FJK
Product Code Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Public Device Record Key
a43e394c-dcc9-4415-bcb3-69fc64284a1d
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
Package DI Number
10850001011218
Quantity per Package
6
Contains DI Package
00850001011211
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |