mcompass Biofeedback 2-Channel Catheter RMD-002-004

GUDID 20851607003079

Medspira mcompass Biofeedback 2-Channel Anorectal Manomtery Catheter

MEDSPIRA, LLC

Rectosphincteric balloon

• Primary Device ID: 20851607003079
• NIH Device Record Key: 0ed8f134-869d-4d66-802c-c36e63ba910b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mcompass Biofeedback 2-Channel Catheter
• Version Model Number: RMD-002-004
• Catalog Number: RMD-002-004
• 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

Customer Support Contacts

• Phone: 612-789-0013
• Email: info@medspira.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851607003075 [Primary]
GS1	10851607003072 [Package]; Contains: 00851607003075; Package: Box [5 Units]; In Commercial Distribution
GS1	20851607003079 [Package]; Contains: 10851607003072; Package: Shipper [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143031

FDA Product Code

• KLA: Monitor, Esophageal Motility, And Tube

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2017-01-06

Devices Manufactured by MEDSPIRA, LLC

• 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