FDA.reportPublic FDA data

Omnipod

Primary DI
10385081120012
Brand
Omnipod
Company
Insulet Corporation
Model
UST400
Catalog number
18900-5A
Device description
Omnipod PDM (Personal Diabetes Manager)
Published
2018-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZGPump, Infusion, Insulin
NBWSystem, Test, Blood Glucose, Over The Counter
NDCCalculator, Drug Dose

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZGPump, Infusion, InsulinGeneral Hospital2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2
NDCCalculator, Drug DoseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20385081120019PackageGS11In Commercial Distribution
10385081120012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2038508112001920385081120019
1038508112001210385081120012

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion pump/blood glucose analyser systemAn assembly of battery-powered portable devices designed to deliver insulin and to measure blood glucose as an aid in the management of diabetes mellitus for a patient requiring insulin. It consists of a portable electronic insulin pump that provides continuous subcutaneous delivery of insulin at set and variable rates, and a wireless microprocessor remote controller that interfaces with the pump to control pump functions and receive pump status information. The controller also incorporates a blood glucose meter and built-in test strip port for the quantitative measurement of glucose in fresh capillary blood.

Contacts#

Phone, Email table
PhoneEmail
800-591-3455xxxx@xxxx.com

Regulatory Flags#

DUNS number
051334402
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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
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
10385083000336Omnipod 5 Controller APPM009-S-AP2024-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10385084000106Omnipod Go Insulin Delivery Device 10U/day PODInsulet CorporationLZG2023-08-18
10385084000151Omnipod Go Insulin Delivery Device 15U/dayInsulet CorporationLZG2023-08-18
10385084000205Omnipod Go Insulin Delivery Device 20U/dayInsulet CorporationLZG2023-08-18
10385084000250Omnipod Go Insulin Delivery Device 25U/dayInsulet CorporationLZG2023-08-18
10385084000304Omnipod Go Insulin Delivery Device 30U/dayInsulet CorporationLZG2023-08-18
10385084000359Omnipod Go Insulin Delivery Device 35U/dayInsulet CorporationLZG2023-08-18
10385084000403Omnipod Go Insulin Delivery Device 40U/dayInsulet CorporationLZG2023-08-18
08809220580000SuperlineSOOIL DEVELOPMENT CO.,LTDLZG2023-06-14
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
20763000497181Extended ReservoirMEDTRONIC MINIMED, INC.LZG2022-09-09
10385081120302Omnipod 5 Controller APPInsulet CorporationNDC2022-02-25
10385083000022Omnipod 5 Controller Insulet CorporationNDC2022-02-25
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22