Catalog Number

1639302

Brand Name

Sapphire

Version/Model Number

1639302

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"

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

K171346,K171346

Product Code

MRZ

Product Code Name

ACCESSORIES, PUMP, INFUSION

Public Device Record Key

b75e8a67-ae3c-4ac3-88ad-1246ab0bbaf2

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

June 01, 2018

Package DI Number

20887787007521

Quantity per Package

50

Contains DI Package

10887787007524

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box