TruWave - Pressure Monitoring Set - Edwards Lifesciences LLC

Duns Number:134139174

Device Description: Pressure Monitoring Set

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More Product Details

Catalog Number

PXVPZ10025

Brand Name

TruWave

Version/Model Number

PXVPZ10025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K142749,K142749

Product Code Details

Product Code

DXO

Product Code Name

Transducer, Pressure, Catheter Tip

Device Record Status

Public Device Record Key

511867b0-7a6f-496a-b13a-99cbcfe03459

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Additional Identifiers

Package DI Number

50690103216801

Quantity per Package

10

Contains DI Package

00690103216806

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"EDWARDS LIFESCIENCES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 643
3 A medical device with high risk that requires premarket approval 212