FDA.reportPublic FDA data

Omnipod (Dash) Display App.

Primary DI
10385081120265
Brand
Omnipod (Dash) Display App.
Company
Insulet Corporation
Model
1.3.1
Catalog number
18239
Device description
Omnipod Display is secondary display app
Published
2021-02-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKUInsulin Pump Secondary Display

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKUInsulin Pump Secondary DisplayClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10385081120265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038508112026510385081120265

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump software, data-displayA software application intended to allow a patient or caregiver to remotely extract and view data from an electronic ambulatory insulin infusion pump to support treatment monitoring; it is not intended to control pump settings. It is intended to be installed on an off-the-shelf device (e.g., smartphone).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
978-600-7155RA@insulet.com
1-800-591-3455RA@insulet.com

Regulatory Flags#

DUNS number
051334402
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10385083000459Omnipod 5 Controller APPM009-2S-AP2025-12-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150034123SFTWR MMT-6101 AHCL APP 3.1 ANDROIDMEDTRONIC MINIMED, INC.PKU2025-09-26
00199150034130MiniMed Mobile AppMEDTRONIC MINIMED, INC.PKU2025-09-26
00850050080169Bionic Circle App, iOSBeta Bionics, Inc.PKU2024-11-13
00850050080176Bionic Circle App, Android Beta Bionics, Inc.PKU2024-11-13
00763000968168MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-09-30
00763000968175MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-09-30
00763000943257MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-07-28
00763000943264MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-07-28
00763000791391CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2024-03-21
00763000910143MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2024-03-08
00763000910150MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2024-03-08
00763000867621MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2023-11-27
00763000867638MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-11-27
00763000521301MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-08-05
00763000827786MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-05-20
00763000827793MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2023-05-20
00763000827298CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2023-05-11
00763000827304CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2023-05-11
00763000432652CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2022-06-25
00763000432645CareLink ™ConnectMEDTRONIC MINIMED, INC.PKU2022-06-24
00763000480646CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2021-03-20
00763000480653CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2021-03-20
00763000480660MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2021-02-21
00763000480677MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2021-02-21
10385081120272Omnipod (Dash) View APPInsulet CorporationPKU2021-02-20
00763000416676MiniMed™ MobileMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000416669MiniMed ™ MobileMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000437794CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2020-11-06
00763000437787CareLink™ ConnectMEDTRONIC MINIMED, INC.PKU2020-11-05
00763000168643Sugar.IQ™MEDTRONIC MINIMED, INC.PKU2018-12-27