Catalog Number

VB-20

Brand Name

ICU Medical

Version/Model Number

VB-20

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K192154,K192154

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

1b20eb5d-51de-41b0-93b9-5f1b4f7fe078

Public Version Date

August 17, 2021

Public Version Number

1

DI Record Publish Date

August 09, 2021

Package DI Number

10887709120591

Quantity per Package

50

Contains DI Package

00887709120594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS