Catalog Number

-

Brand Name

Pump Tubing Infusion Line with SmartSense Tag

Version/Model Number

TUB500-RFID

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"

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

FEN

Product Code Name

Device, Cystometric, Hydraulic

Public Device Record Key

f0afabc3-bc05-40fd-808b-96e8c5a1fe1e

Public Version Date

October 14, 2019

Public Version Number

1

DI Record Publish Date

October 04, 2019

Package DI Number

10627825012574

Quantity per Package

25

Contains DI Package

00627825012577

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-