| Primary Device ID | 04056869997445 |
| NIH Device Record Key | c5f2172c-f3ea-46e2-a9b8-e696cf9a9e1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AcuNav Lumos 4D ICE catheter |
| Version Model Number | 11658641 |
| Company DUNS | 804722783 |
| Company Name | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Catheter Gauge | 12.5 French |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 23 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04056869997445 [Primary] |
| OBJ | Catheter, ultrasound, intravascular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
[04056869997445]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-07-29 |
| Device Publish Date | 2024-07-19 |
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