ACUMEN IQ SENSOR FOR AFM - ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID - Edwards Lifesciences LLC

Duns Number:134139174

Device Description: ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE ACUMEN IQ 84" / 213CM FOR USE WITH ASSISTED FLUID MANAGEMENT SOFTWARE FEATURE RED CAP FIVE PACK

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More Product Details

Catalog Number

AIQSAFM8R5

Brand Name

ACUMEN IQ SENSOR FOR AFM

Version/Model Number

AIQSAFM8R5

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

K152980,K152980

Product Code Details

Product Code

DRS

Product Code Name

Transducer, Blood-Pressure, Extravascular

Device Record Status

Public Device Record Key

d7bfca10-57ab-4d6c-92f9-58385c6e2bb8

Public Version Date

July 17, 2019

Public Version Number

1

DI Record Publish Date

July 09, 2019

Additional Identifiers

Package DI Number

50690103201067

Quantity per Package

5

Contains DI Package

00690103201062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper

"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