| Primary Device ID | 10385083000213 |
| NIH Device Record Key | 83f9e052-d144-4469-8ea5-c1bc6b9937e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnipod 5 Pod |
| Version Model Number | POD-BLE-H1-520 |
| Company DUNS | 051334402 |
| Company Name | INSULET CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| xxxx@xxx.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com | |
| Phone | 1-800-591-3455 |
| RegulatoryAffairs@insulet.com |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10385083000114 [Primary] |
| GS1 | 10385083000138 [Package] Contains: 10385083000114 Package: 10 Pack Box [10 Units] In Commercial Distribution |
| GS1 | 10385083000213 [Package] Contains: 10385083000114 Package: 5 Pack Box [5 Units] In Commercial Distribution |
| GS1 | 20385083000135 [Package] Contains: 10385083000114 Package: 10 Pack Box [10 Units] In Commercial Distribution |
| GS1 | 20385083000210 [Package] Contains: 10385083000114 Package: 5 Pack Box [5 Units] In Commercial Distribution |
| QFG | Alternate Controller Enabled Insulin Infusion Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-07 |
| Device Publish Date | 2022-02-25 |
| 10385083000213 | Omnipod 5 Pod |
| 20385083000531 | Omnipod 5 Pod |