General Hospital and Personal Use Devices

md

General Hospital and Personal Use Devices

medical_device

Lot Codes: L41908, L41910, F41935

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

OmniPod¿, Insulin Management System (OUS) || Catalog Number: 14810 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

OmniPod¿, Insulin Management System (US) || Catalog Number: PODZXP420 || Product Usage: || The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208  Expanded Recall: Lot Codes: L41908, L41910, F41935

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250  Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

General Hospital and Personal Use Devices

2

No

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Omnipod is a medical device licensed for sale in Canada to control blood sugar levels in people with diabetes who need insulin, the device delivers insulin for up to 3 days.

General Hospital and Personal Use Devices

Injections / Infusions / Transfusions / Dialysis - infusion technology

General Hospital and Personal Use Devices

Medical-electromechanical equipment

Lot Numbers: L13470

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA Nationwide and the country of Israel.

OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) || Product Usage: || The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.

Lot Numbers: L13483, L13485, L13478, & L13481

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA Nationwide and the country of Israel.

OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) || Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.

Insulet Corporation: OmniPod® insulin management system

14810 | L40771, L40892, L40901, L40905, L40997, L41199, L41208

MD: Ambulatory insulin infusion pump

Model Catalog: CAT45F (Lot serial: All lots); Model Catalog: PDM-CAT35E (Lot serial: All lots); Model Catalog: PDM-CAT35F (Lot serial: All lots); Model Catalog: CAT45E (Lot serial: All lots)

OmniPod Insulin Management System

General Hospital and Personal Use Devices

General Hospital and Personal Use Devices

General Hospital and Personal Use Devices