Catalog Number

1636402

Brand Name

Sapphire

Version/Model Number

1636402

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

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

-

Product Code

MRZ

Product Code Name

ACCESSORIES, PUMP, INFUSION

Public Device Record Key

76dd9e5c-d8f3-40a3-b8d8-4dd6c66eef68

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2017

Package DI Number

20887787007378

Quantity per Package

50

Contains DI Package

10887787007371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case