| Primary Device ID | 10851607003416 |
| NIH Device Record Key | df932e60-fa6b-48ff-84bc-27550fa909f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack |
| Version Model Number | RMD-202-007 |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com | |
| Phone | 612-789-0013 |
| iinfo@medspira.com |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Product should be kept dry |
| Handling Environment Temperature | Between 2 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851607003419 [Primary] |
| GS1 | 10851607003416 [Package] Contains: 00851607003419 Package: Box [5 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 |
| 10851607003515 - 5-Pack, 100 cc Syringe, Luer-locking | 2024-12-30 Syringe, Luer-Locking, 100cc, 5-Pack |
| 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 |
| 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 |