Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply

GUDID 10851607003317

MEDSPIRA, LLC

Manometric gastrointestinal motility analysis system

• Primary Device ID: 10851607003317
• NIH Device Record Key: d3d217eb-1320-40be-b1f5-119ff2993e6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply
• Version Model Number: RMD-010-004
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851607003310 [Primary]
GS1	10851607003317 [Package]; Contains: 00851607003310; Package: Shipper [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143031

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: 2022-02-14
• Device Publish Date: 2022-02-04

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