Catalog Number

-

Brand Name

Pressure Relief Manifold 12.5 cm H20/T-connector/Tube/Cap

Version/Model Number

CT-13540

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Public Device Record Key

f3506b90-7979-4abd-92ea-5074b84937da

Public Version Date

August 05, 2022

Public Version Number

3

DI Record Publish Date

December 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-