LF - OptiStar Elite, Fixed Height Stand Assembly - Liebel-Flarsheim Company LLC

Duns Number:080186051

Device Description: OptiStar Elite, Fixed Height Stand Assembly (Accessory)

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More Product Details

Catalog Number

802850S

Brand Name

LF

Version/Model Number

802850

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

e3e89219-347b-47e3-83d9-dafd80d6928b

Public Version Date

January 05, 2022

Public Version Number

3

DI Record Publish Date

September 10, 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