Catalog Number

FP-0010002

Brand Name

SCIg60 Infusion System

Version/Model Number

FP-0010002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K142319

Product Code

PKP

Product Code Name

Immunoglobulin G (Igg) Infusion System

Public Device Record Key

364e8ce6-8ce6-4f64-b5d8-6a56fb2f523d

Public Version Date

June 17, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-