FDA.reportPublic FDA data

Omnipod DASH PDM

Primary DI
10385082000009
Brand
Omnipod DASH PDM
Company
Insulet Corporation
Model
PDM-USA1-D001-MG-USA1
Device description
Omnipod DASH Personal Diabetes Manager (PDM) mg/dL
Published
2025-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
10385081140010PackageGS11In Commercial Distribution
10385082000542PackageGS11In Commercial Distribution
10385082000009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038508114001010385081140010
1038508200054210385082000542
1038508200000910385082000009

GMDN Terms#

Term, Definition table
TermDefinition
Ambulatory insulin infusion administration unit/remote control systemAn assembly of devices intended to provide remotely-controlled basal and/or periodic bolus subcutaneous delivery of insulin to a patient with diabetes mellitus. It consists of a badge-like, battery-powered, disposable device (electromechanical pumping unit, an insulin reservoir filled by the patient, and an administration cannula/needle) designed to adhere to skin or clothing (e.g., with a pressure-sensitive adhesive), and a wireless unit with dedicated software that interfaces with the pump to control and program pump functions and receive pump status information. The remote control may be capable of data transmission to other platforms.

Contacts#

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

Regulatory Flags#

DUNS number
051334402
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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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00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
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