Omnipod Insulin Management System 18900-5M
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- Omnipod Insulin Management System EUDAMED
- Device Name
- PDM-NOT450 EUDAMEDPDM-ATT400 EUDAMEDSKT-ITT400 EUDAMEDPDM-SVT450 EUDAMEDEROS Starter Kit EUDAMEDSKT-FIT450 EUDAMEDPDM-DAT450 EUDAMEDPart No. 18916-6F, SKT-DET456 EUDAMEDSKT-DET450 EUDAMEDOmnipod Insulin Management System EUDAMEDPDM-ITT400 EUDAMED
- Model / Reference
- 18900-5M EUDAMED18900-5S EUDAMED18916-5K EUDAMED18900-5N EUDAMEDOmnipod Insulin Management System EUDAMEDNLT450 EUDAMED18916-9H EUDAMED18900-5T EUDAMED18916-6F EUDAMED18916-5F EUDAMED18900-6F EUDAMED18900-5K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10385081120135 EUDAMED10385081120159 EUDAMED20385081120125 EUDAMED10385081120142 EUDAMED20385081120118 EUDAMED20385081120200 EUDAMED10385081120166 EUDAMED20385081120170 EUDAMED20385081120095 EUDAMED10385081120173 EUDAMED10385081120128 EUDAMED
- Basic UDI-DI
- B-10385081120135 EUDAMEDB-10385081120159 EUDAMEDB-20385081120125 EUDAMEDB-10385081120142 EUDAMEDB-20385081120118 EUDAMEDB-20385081120200 EUDAMEDB-10385081120166 EUDAMEDB-20385081120170 EUDAMEDB-20385081120095 EUDAMEDB-10385081120173 EUDAMEDB-10385081120128 EUDAMED
- 510(k) Number
- K192659 FDA 510(k)
- FDA Product Code
- LZG FDA 510(k)
- EMDN Code
- Z120402160101 PORTABLE INSULIN MICROINFUSORS EUDAMEDZ120402160102 PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER EUDAMEDZ120402160103 PORTABLE INSULIN MICROINFUSORS CONNECTABLE TO CONTINUOUS GLUCOSE MONITORING SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 880.5725 FDA 510(k)
- Regulation Number
- 880.5725 FDA 510(k)
- Market of Registration
- Norway EUDAMEDAustria EUDAMEDItaly EUDAMEDSweden EUDAMEDNetherlands EUDAMEDFinland EUDAMEDDenmark EUDAMEDGermany EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
Yes
Incorporates Medicinal Product
No
The Omnipod Insulin Management System is a medical device designed for the administration of insulin. It functions as an active device with a measuring function to assist in the management of insulin delivery.
This system is identified by model number 18900-5M and is manufactured by Insulet Corporation. It is a non-implantable, single-use device that is not supplied sterile and does not contain latex or animal tissues.
Frequently asked questions
Is the Omnipod Insulin Management System reusable?
No, the device is not reusable. It is designed for single-use applications to ensure proper hygiene and functionality for insulin administration.
Does the Omnipod system contain latex?
No, the Omnipod Insulin Management System is manufactured without the use of latex, making it suitable for individuals with latex sensitivities.
Is the Omnipod Insulin Management System an implantable device?
No, the device is not implantable. It is an external system designed to administer insulin as specified by the manufacturer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Automatisierte Insulin-Dosierung leicht gemacht | Omnipod DE, Omnipod® 5: Automatisierte Insulin-Dosierung leicht gemacht | Omnipod …, Dexcom G7 und Omnipod 5:, Melden Sie sich bei Ihrem Online-Omnipod®-Konto an, Das kann der Omnipod 5 | Diasticker® - Diabeteszubehör
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192659 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K131294 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K162296 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K160252 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K140439 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K122953 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-10385081120135 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Insulet Corporation
- EUDAMED SRN
- US-MF-000007948
- Authorised Representative
- Insulet Netherlands B.V. NL-AR-000002337
Sources (12)
- EUDAMED 499493c4-0bb9-44e9-9491-57fdd4dc1379 61 fields · synced Sep 18, 2026
- EUDAMED a840137c-ac6b-4805-896a-c3ea74b2d81e 61 fields · synced May 16, 2026
- EUDAMED cd2f800f-efb2-4daa-8a21-3c70ecaf4d60 61 fields · synced May 17, 2026
- EUDAMED 0fc9aac5-4da7-49c6-9619-82f4779da527 61 fields · synced May 17, 2026
- EUDAMED 7f41b8dc-c76e-4582-8930-f1427e351194 61 fields · synced May 17, 2026
- EUDAMED 8670c37c-acb4-4b58-a9fa-06e489ffcd4b 61 fields · synced May 17, 2026
- EUDAMED 4c6ccf59-b616-49b0-b2ca-d068c4f0c83e 61 fields · synced May 17, 2026
- EUDAMED 83b257b3-0d65-4a4e-a0a9-6699cf6d8ab0 61 fields · synced May 18, 2026
- EUDAMED 4922312b-acae-417d-8026-c49ac9c7a9d1 61 fields · synced May 18, 2026
- EUDAMED 430c8a9a-b437-41bf-baa4-0b3071bb1e69 61 fields · synced May 18, 2026
- FDA 510(k) K192659 24 fields · synced May 18, 2026
- EUDAMED c6e427d5-f035-4f86-a420-9b87a9d43c2d 61 fields · synced Jul 19, 2026