FloTrac, VAMP Optima - FloTrac sensor with VAMP Optima system - Edwards Lifesciences LLC

Duns Number:134139174

Device Description: FloTrac sensor with VAMP Optima system

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More Product Details

Catalog Number

MHD8VZ

Brand Name

FloTrac, VAMP Optima

Version/Model Number

MHD8VZ

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

K180275

Product Code Details

Product Code

FMG

Product Code Name

Stopcock, I.V. Set

Device Record Status

Public Device Record Key

16e3acf5-2730-40e3-bb55-96038cc3e45d

Public Version Date

November 30, 2018

Public Version Number

1

DI Record Publish Date

October 30, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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