mcompass Anorectal Manometry Software

GUDID 00851607003204

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system Manometric gastrointestinal motility analysis system

• Primary Device ID: 00851607003204
• NIH Device Record Key: 8c7a2481-7dcd-44cb-b75b-0818d9830082
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mcompass Anorectal Manometry Software
• Version Model Number: RMD-001-003
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851607003204 [Primary]

FDA Product Code

• KLA: Monitor, Esophageal Motility, Anorectal Motility, And Tube

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-09
• Device Publish Date: 2021-07-01

Devices Manufactured by MEDSPIRA, LLC

• 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
• 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