Catalog Number

PXVPL0029

Brand Name

TRUWAVE(3 CC)/ VAMP PLUS 86 IN (218 CM)

Version/Model Number

PXVPL0029

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K141495,K142749,K161962,K141495,K142749,K161962

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Public Device Record Key

c8277b29-28c2-4efd-bffb-5373c4b95d68

Public Version Date

August 08, 2019

Public Version Number

4

DI Record Publish Date

May 30, 2019

Package DI Number

50690103197681

Quantity per Package

10

Contains DI Package

00690103197686

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper