Catalog Number

17000-033-0001

Brand Name

SapphirePlus Infusion Kit - US

Version/Model Number

17000-033-0001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 22, 2018

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"

-

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

K141389,K141389,K141389

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

74037d6c-a745-4600-819c-9e49ee081383

Public Version Date

July 04, 2022

Public Version Number

5

DI Record Publish Date

September 01, 2016

Package DI Number

27290109150158

Quantity per Package

8

Contains DI Package

17290109150151

Package Discontinue Date

February 22, 2018

Package Status

Not in Commercial Distribution

Package Type

cardboard box