Catalog Number

1637101

Brand Name

Sapphire

Version/Model Number

1637101

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

-

Product Code

MRZ

Product Code Name

ACCESSORIES, PUMP, INFUSION

Public Device Record Key

7b55a26f-771e-443c-a05c-4071df8fd9a1

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 31, 2017

Package DI Number

20887787007385

Quantity per Package

50

Contains DI Package

10887787007388

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case