Catalog Number

15079-111-0001

Brand Name

Sapphire External Battery Pack

Version/Model Number

15079-111-0001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123049,K123049,K123049

Product Code

MRZ

Product Code Name

Accessories, Pump, Infusion

Public Device Record Key

db18d422-cbc3-402b-9285-8621779a0578

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

27290109150080

Quantity per Package

10

Contains DI Package

17290109150083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box