Duns Number:788744477
Device Description: Tablo Cartridge with Needleless Infusion Ports Type B
Catalog Number
CART-201
Brand Name
Tablo Needleless Cartridge, B
Version/Model Number
PN-0002572
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 03, 2020
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,K140841
Product Code
FJK
Product Code Name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Public Device Record Key
8de71e08-d315-41b7-b471-9a0dea9220fa
Public Version Date
August 04, 2020
Public Version Number
6
DI Record Publish Date
June 05, 2017
Package DI Number
10850001011089
Quantity per Package
6
Contains DI Package
00850001011082
Package Discontinue Date
August 03, 2020
Package Status
Not in Commercial Distribution
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 |