Catalog Number

17000-031-0035

Brand Name

Sapphire Epidural Infusion Pump Kit – US

Version/Model Number

17000-031-0035

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"

-

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

K192860,K192860,K192860

Product Code

FRN

Product Code Name

Pump, Infusion

Public Device Record Key

0b5bd786-2cf9-4c52-8e1e-8b9473e61ab3

Public Version Date

July 04, 2022

Public Version Number

3

DI Record Publish Date

May 15, 2022

Package DI Number

27290109154279

Quantity per Package

8

Contains DI Package

17290109154272

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard box