mcompass Anorectal Manometry System RMD-001

GUDID 10851607003058

Medspira mcompass Diagnostic Anorectal Manometry system

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system

• Primary Device ID: 10851607003058
• NIH Device Record Key: 0cd4a39c-a42f-4f29-9fad-1d23290216db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mcompass Anorectal Manometry System
• Version Model Number: RMD-001
• Catalog Number: RMD-001
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851607003051 [Primary]
GS1	10851607003058 [Package]; Contains: 00851607003051; Package: Shipper [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120088

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

On-Brand Devices [mcompass Anorectal Manometry System]

• 10851607003058: Medspira mcompass Diagnostic Anorectal Manometry system
• 10851607003393: mcompass Anorectal Manometry System