| Primary Device ID | 10851607003386 |
| NIH Device Record Key | 35d1ac5a-a034-4989-ba63-9bcab3bc61e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | System Accessory Kit |
| Version Model Number | RMD-010-011 |
| 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 | true |
| 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 |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com | |
| Phone | 612-789-0013 |
| support@medspira.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851607003389 [Primary] |
| GS1 | 10851607003386 [Package] Contains: 00851607003389 Package: Bag [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 | 2024-12-09 |
| Device Publish Date | 2024-11-30 |
| 10851607003003 - QuikLinq FOB Adapter | 2025-03-18 Adapter for QuikLinq FOB |
| 10851607003539 - 5-Pack, Luer-Locking, 100cc Syringe | 2025-03-11 100cc Syringe, Luer-Locking, 5-Pack |
| 10851607003515 - 5-Pack, 100 cc Syringe, Luer-locking | 2024-12-30 Syringe, Luer-Locking, 100cc, 5-Pack |
| 10851607003386 - System Accessory Kit | 2024-12-09Accessories for mcompass systems |
| 10851607003386 - System Accessory Kit | 2024-12-09 Accessories for mcompass systems |
| 00851607003525 - Battery, Tablet PC | 2024-12-09 Battery for Tablet PC |
| 00851607003327 - Single Patient Kit, mcompass, Anorectal Manometry 5-channel | 2023-10-16 Single Patient Kit, mcompass, Anorectal Manometry 5-channel |
| 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 |