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

Alternate Controller Enabled Insulin Infusion Pump (QFG) (2) Interoperable Automated Glycemic Controller (QJI) (2) Calculator, Drug Dose (NDC) (1) Continuous Glucose Monitor Informed Insulin Dose Calculator (QRX) (1)

Premarket Exempt

No Yes

Clear

Omnipod 5 Controller - 10385083000022 Catalog Number : SKT-H001-G-X9

Device Description : Omnipod 5 Controller (PDM) mg/dl - English with PodPals

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : QFG, QJI, QRX, NDC

Prescription Use : Yes

Device Count : 1

Omnipod 5 Pod - 10385083000114 Catalog Number :

Device Description : Omnipod 5 Pod

Device Class :

Duns Number: 051334402

Premarket Exempt : No

Product Code : QFG, QJI

Prescription Use : Yes

Device Count : 1

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