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Devices
Roche AccuCheck Spirit
Model / Serial
All Serial Numbers Models: 1. 05458544001, Accu-Chek Combo Kit mg US/English version. 2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4. 05391750001, Accu-Chek Spirit Combo Demo Pump US. 5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6. 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7. 04759729001, Accu-Chek Spirit Replacement Pump.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution
Product Description
AccuChek Spirit insulin infusion pump.
Manufacturer
Roche Diabetes Care, Inc.
2 Events
Recall of Roche AccuCheck Spirit
Recall of Roche AccuCheck Spirit
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Manufacturer
Roche Diabetes Care, Inc.
Manufacturer Address
Roche Diabetes Care, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
Manufacturer Parent Company (2017)
Roche Holding AG
Source
USFDA
Language
English
Français
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한국어