FDA.reportPublic FDA data

Omnipod 5 Controller APP

Primary DI
10385083000459
Brand
Omnipod 5 Controller APP
Company
Insulet Corporation
Model
M009-2S-AP
Device description
Omnipod 5 Controller APP iOS V2.x
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJIInteroperable Automated Glycemic Controller
QRXContinuous Glucose Monitor Informed Insulin Dose Calculator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJIInteroperable Automated Glycemic ControllerClinical Chemistry2
QRXContinuous Glucose Monitor Informed Insulin Dose CalculatorClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385083000459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038508300045910385083000459

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/interstitial glucose monitoring systemAn assembly of portable devices intended to simultaneously continuously monitor interstitial glucose levels and subcutaneously infuse insulin in patients with diabetes. Sometimes referred to as a closed loop artificial pancreas, it consists of a percutaneous blood glucose monitoring system (CGM), an ambulatory insulin infusion pump, and software on a dedicated handset or transmitter capable of telemetric communication with the other components. The software contains an algorithm to allow continuous communication between the two devices, and may enable the manual input of data with respect to meals and physical activity.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-591-3455RA@insulet.com

Regulatory Flags#

DUNS number
051334402
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10385081120265Omnipod (Dash) Display App.1.3.1182392021-02-20
10385081120272Omnipod (Dash) View APP1.3.1182392021-02-20
10385083000411Omnipod 5 PodPOD-OMNI-I1-62202025-12-04
10385083000152Omnipod Discover B010-D-DP2025-12-04
20385083000425Omnipod 5 PodPOD-OMNI-I1-62202025-12-04
10385081120333Omnipod PodPalsPOD-X9-990NS2025-04-16
10385083000114Omnipod 5 PodPOD-BLE-H1-5202022-02-25
10385083000527Omnipod 5 PodPOD-OMNI-I1-67202024-02-22
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODPOD-INS-I1-10252023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayPOD-INS-I1-15252023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayPOD-INS-I1-20252023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayPOD-INS-I1-25252023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayPOD-INS-I1-30252023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayPOD-INS-I1-35252023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayPOD-INS-I1-40252023-08-18
20385081120330Omnipod PodPalsPOD-X9-990NS2025-04-16
10385081120234Omnipod PodPalsPOD-X9-9902019-07-01
10385082000009Omnipod DASH PDMPDM-USA1-D001-MG-USA12025-08-25
10385081120012OmnipodUST40018900-5A2018-03-05
10385083000336Omnipod 5 Controller APPM009-S-AP2024-07-22

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Primary DI, Brand, Company table
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00389152857572Tandem t:slim Autosoft XC KitTandem Diabetes Care, Inc.QJI2025-12-10
10385083000411Omnipod 5 PodInsulet CorporationQJI2025-12-04
00389152707679Tandem t:slim Autosoft 30 kitTandem Diabetes Care, Inc.QJI2025-05-23
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