Catalog Number

-

Brand Name

IV Plus

Version/Model Number

BS0657

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

K081123,K081123

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

eb53e386-e8b4-450b-8d53-20ad3479a43d

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 26, 2021

Package DI Number

30815879021381

Quantity per Package

1000

Contains DI Package

10815879021387

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-