Catalog Number

-

Brand Name

NIPRO SOLUTION INFUSION SET

Version/Model Number

IS-01-A/A-21G

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

f1516b83-f6f5-4988-9bcf-19aac4d4ce00

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

10383790003367

Quantity per Package

100

Contains DI Package

00383790003360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-