ICU Medical - PULMONARY ARTERY MONITORING KIT WITH 03ML FLUSH - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: PULMONARY ARTERY MONITORING KIT WITH 03ML FLUSH DEVICE

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More Product Details

Catalog Number

460970474

Brand Name

ICU Medical

Version/Model Number

46097-74

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K052828,K052828

Product Code Details

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Device Record Status

Public Device Record Key

776aaff3-9e83-43b9-8218-33ca52366ff8

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Additional Identifiers

Package DI Number

10840619065000

Quantity per Package

10

Contains DI Package

00840619065003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"ICU MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4887