INSULET CORPORATION

Address:600 Technology Park Dr Suite 200,Billerica,MA,01821,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Pump, Infusion, Insulin (LZG) (6) Calculator, Drug Dose (NDC) (6) System, Test, Blood Glucose, Over The Counter (NBW) (4) Insulin Pump Secondary Display (PKU) (2) Alternate Controller Enabled Insulin Infusion Pump (QFG) (1) Continuous Glucose Monitor Informed Insulin Dose Calculator (QRX) (1) Tape And Bandage, Adhesive (KGX) (1)

Premarket Exempt

No Yes

Clear

Omnipod - 10385081120005 Catalog Number : 14000

Device Description : Eros Pod Insulin pump.

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : LZG, NBW, NDC

Prescription Use : Yes

Device Count : 1

Omnipod - 10385081120012 Catalog Number : 18900-5A

Device Description : Eros PDM (Personal Diabetes Manager)

Device Class : 2

Duns Number: 051334402

Premarket Exempt : No

Product Code : NBW, LZG, NDC

Prescription Use : Yes

Device Count : 1

Omnipod - 10385081120036 Catalog Number : 19191

Device Description : Eros Pod Insulin Pump.

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : LZG, NBW, NDC

Prescription Use : Yes

Device Count : 1

Omnipod PodPals - 10385081120234 Catalog Number :

Device Description : Omnipod Adhesive Overlay (Podpals)

Device Class :

Duns Number: 051334402

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 1

Omnipod (Dash) Display App. - 10385081120265 Catalog Number : 18239

Device Description : Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump s Mobile App utilized in the PDM (Personal Device Manager) for Dash Insulin pump secondary display. PDM Device 18239; app 41252

Device Class : 2

Duns Number: 051334402

Premarket Exempt : Yes

Product Code : PKU

Prescription Use : No

Device Count : 1

Omnipod (Dash) View APP - 10385081120272 Catalog Number : 18239

Device Description : Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump Mobile App utilized in the PDM (Personal Device Manager) for Dash. Insulin pump secondary display. PDM Device 18239; app 41253

Device Class : 2

Duns Number: 051334402

Premarket Exempt : Yes

Product Code : PKU

Prescription Use : No

Device Count : 1

Omnipod 5 Controller APP - 10385081120302 Catalog Number :

Device Description : Actual downloadable APP, called Omnipod 5 Controller APP

Device Class : 2

Duns Number: 051334402

Premarket Exempt : No

Product Code : QFG, QRX, NDC

Prescription Use : No

Device Count : 1

Omnipod - 10385081140003 Catalog Number : 14500-5A

Device Description : Eros PDM(Personal Diabetes Manager)

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : NBW, LZG, NDC

Prescription Use : Yes

Device Count : 1

Omnipod DASH Starter Kit - 10385082000009 Catalog Number : SKT -USA 1-DOO 1-MG-ENG

Device Description : Starter Kit (PDM) mg/dL - Dash, english

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : NDC, LZG

Prescription Use : Yes

Device Count : 1

Omnipod DASH Pod - 10385082000023 Catalog Number :

Device Description : DASH Pod

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : LZG

Prescription Use : Yes

Device Count : 1

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