Catalog Number

1642101

Brand Name

Sapphire

Version/Model Number

1642101

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

K171346,K171346

Product Code

MRZ

Product Code Name

ACCESSORIES, PUMP, INFUSION

Public Device Record Key

69e8f3a6-ec7a-4099-a8f1-625fef50845b

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

May 31, 2018

Package DI Number

20887787007552

Quantity per Package

48

Contains DI Package

10887787007555

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case