| Primary Device ID | 10851607003393 |
| NIH Device Record Key | bfd9af03-f46c-4054-a9af-df64fc622316 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | mcompass Anorectal Manometry System |
| Version Model Number | RMD-001U |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com | |
| Phone | 612-789-0013 |
| info@medspira.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851607003396 [Primary] |
| GS1 | 10851607003393 [Package] Contains: 00851607003396 Package: Shipper [1 Units] In Commercial Distribution |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-16 |
| Device Publish Date | 2023-10-06 |
| 10851607003058 | Medspira mcompass Diagnostic Anorectal Manometry system |
| 10851607003393 | mcompass Anorectal Manometry System |