| Primary Device ID | 00850040691054 |
| NIH Device Record Key | 8305fe05-9612-44d5-8146-a5c1698aaa71 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FreedomFlow Orbital Circumferential Atherectomy System |
| Version Model Number | H6002 |
| Company DUNS | 080505958 |
| Company Name | Cardio Flow, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net | |
| Phone | 800-294-5517 |
| customerservice@cardioflow.net |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Atherectomy Rotating Component | 2 Millimeter |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 15 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850040691054 [Primary] |
| GS1 | 90850040691064 [Package] Package: Case [5 Units] In Commercial Distribution |
| MCW | Catheter, Peripheral, Atherectomy |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
[00850040691054]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-01 |
| Device Publish Date | 2024-06-21 |
| 00850040691085 | FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 3-Spher |
| 00850040691054 | FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 6Fr 135 cm, 5-spher |
| 00850040691030 | FreedomFlow Orbital Circumferential Atherectomy System Electric User Handle, 5Fr 150 cm, 5-spher |