LF - Illumena Neo Contrast Delivery System, Powerpack - Liebel-Flarsheim Company LLC

Duns Number:080186051

Device Description: Illumena Neo Contrast Delivery System, Powerpack Rackmount (Accessory)

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More Product Details

Catalog Number

900613SR

Brand Name

LF

Version/Model Number

900613

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"

-

For Single-Use

-

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

-

Product Code Details

Product Code

FOX

Product Code Name

Stand, Infusion

Device Record Status

Public Device Record Key

5d2f7a7a-25f7-4806-98fd-287be80b88c7

Public Version Date

January 05, 2022

Public Version Number

3

DI Record Publish Date

November 02, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIEBEL-FLARSHEIM COMPANY LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 75