Catalog Number

17000-020-0008

Brand Name

Sapphire Multi-Pump Mounting System Power Supply – US

Version/Model Number

17000-020-0008

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"

-

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

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

cc4694bf-fabb-47db-9cf3-1809a8b951a3

Public Version Date

May 23, 2022

Public Version Number

1

DI Record Publish Date

May 15, 2022

Package DI Number

27290109153913

Quantity per Package

4

Contains DI Package

17290109153930

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-