| Primary Device ID | 00851607003211 |
| NIH Device Record Key | 30f0f233-3365-43e4-9bda-2594dfb8834d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | mcompass Biofeedback Manometry Software |
| Version Model Number | RMD-002-001 |
| Company DUNS | 962187964 |
| Company Name | MEDSPIRA, LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| 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 |
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| 00851607003334 - Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite | 2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite |
| 10851607003348 - Single Patient Kit, mcompass, Anorectal Manometry 2-channel | 2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 2-channel |
| 10851607003379 - Medspira Tablet PC with Power Supply | 2023-10-16 Medspira Tablet PC with Power Supply |
| 10851607003393 - mcompass Anorectal Manometry System | 2023-10-16 mcompass Anorectal Manometry System |
| 00851607003402 - Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack | 2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack |
| 10851607003416 - Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack | 2023-10-16 Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack |
| 10851607003423 - Catheter, mcompass®, Biofeedback, 2-channel, 5-pack | 2023-10-16 Catheter, mcompass®, Biofeedback, 2-channel, 5-pack |