FDA.reportPublic FDA data

Omnipod

Primary DI
10385081120005
Brand
Omnipod
Company
Insulet Corporation
Model
ZXP420
Catalog number
14000
Device description
Eros Pod Insulin pump.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
20385081120002PackageGS110In Commercial Distribution
20385081120057PackageGS15In Commercial Distribution
20385081120101PackageGS110Not in Commercial Distribution
10385081120005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2038508112000220385081120002
2038508112005720385081120057
2038508112010120385081120101
1038508112000510385081120005

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2Milliliter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10385082000009Omnipod DASH PDMPDM-USA1-D001-MG-USA12025-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815241ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815258ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815265ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.NBW2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.NBW2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.NBW2026-07-30
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
00860015091604KetoBMKETOBM USA LLCNBW2026-07-14
00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13