Accu-Chek Spirit Cartridge 05206073001

GUDID 04015630882908

Accu-Chek Spirit 3.15ml Cart. Sys. 25pc

Roche Diabetes Care GmbH

Ambulatory insulin infusion pump reservoir
Primary Device ID04015630882908
NIH Device Record Keyfad7911f-a55b-416c-956a-92e1d726fafb
Commercial Distribution Discontinuation2022-05-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAccu-Chek Spirit Cartridge
Version Model Number05206073001
Catalog Number05206073001
Company DUNS313212471
Company NameRoche Diabetes Care GmbH
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104015630882908 [Primary]
GS154015630882903 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZGPump, Infusion, Insulin

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


[04015630882908]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-07-25
Device Publish Date2016-08-26

On-Brand Devices [Accu-Chek Spirit Cartridge]

04015630882908Accu-Chek Spirit 3.15ml Cart. Sys. 25pc
04015630882755Accu-Chek Spirit 3.15ml Cart. Sys. 5pcs

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