Catalog Number

05206073001

Brand Name

Accu-Chek Spirit Cartridge

Version/Model Number

05206073001

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K042887,K042887

Product Code

LZG

Product Code Name

Pump, Infusion, Insulin

Public Device Record Key

fad7911f-a55b-416c-956a-92e1d726fafb

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

August 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-