Catalog Number

-

Brand Name

NIPRO SOLUTION INFUSION SET

Version/Model Number

IS-01-A/A-21GS 

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"

-

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

K101958,K101958,K101958

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

a8dc3dc3-8311-4e82-bcd8-831f08eaaaa7

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

40383790005737

Quantity per Package

4

Contains DI Package

10383790005736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-