Search Results
Found 6 results
510(k) Data Aggregation
K Number
K243273Device Name
CeQur Simplicity On-Demand Insulin Delivery System
Manufacturer
CeQur SA
Date Cleared
2024-11-13
(28 days)
Product Code
OPP
Regulation Number
880.5725Why did this record match?
Product Code :
OPP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Device Description
The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The CeQur Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
Ask a Question
K Number
K233447Device Name
CeQur Simplicity On-Demand Insulin Delivery System
Manufacturer
CeQur SA
Date Cleared
2024-01-18
(91 days)
Product Code
OPP
Regulation Number
880.5725Why did this record match?
Product Code :
OPP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CeQur Simplicity™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Device Description
The CeQur Simplicity™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyroqenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 4 days (96 hours) using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Insed to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The Cequr Simplicity™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
Ask a Question
K Number
K163357Device Name
OneTouch Via On-Demand Insulin Delivery System
Manufacturer
LifeScan Europe, a division of Cilag GmbH
Date Cleared
2017-06-07
(189 days)
Product Code
OPP, LZG
Regulation Number
880.5725Why did this record match?
Product Code :
OPP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Device Description
The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive.
The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
Ask a Question
K Number
K111924Device Name
FINESSE PERSONAL INSULIN DELIVERY PATCH
Manufacturer
CALIBRA MEDICAL, INC.
Date Cleared
2012-04-10
(279 days)
Product Code
OPP, LZG
Regulation Number
880.5725Why did this record match?
Product Code :
OPP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus.
The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Device Description
The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.
The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery.
The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.
Ask a Question
K Number
K100947Device Name
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
Manufacturer
CALIBRA MEDICAL, INC.
Date Cleared
2010-06-28
(83 days)
Product Code
OPP
Regulation Number
880.5725Why did this record match?
Product Code :
OPP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
Device Description
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and a drug delivery device filler. The device is adhered to the skin with a biocompatible adhesive.
The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component.
The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
Ask a Question
K Number
K093065Device Name
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
Manufacturer
CALIBRA MEDICAL, INC.
Date Cleared
2010-01-20
(112 days)
Product Code
OPP, LZG
Regulation Number
880.5725Why did this record match?
Product Code :
OPP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
Device Description
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and drug delivery device filler. The device is adhered to the skin for up to 48 hours with a biocompatible adhesive. The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component. The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
Ask a Question
Page 1 of 1