Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite

GUDID 00851607003334

Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite

MEDSPIRA, LLC

Rectosphincteric balloon

• Primary Device ID: 00851607003334
• NIH Device Record Key: 3cb05198-f8f7-4a19-9610-995d41ec3891
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite
• Version Model Number: RMD-002-010
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• 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
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com
• Phone: 612-789-0013
• Email: info@medspira.com

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00851607003334 [Primary]
GS1	10851607003331 [Package]; 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: 2023-10-16
• Device Publish Date: 2023-10-06

Devices Manufactured by MEDSPIRA, LLC

• 10851607003003 - QuikLinq FOB Adapter: 2025-03-18 Adapter for QuikLinq FOB
• 10851607003539 - 5-Pack, Luer-Locking, 100cc Syringe: 2025-03-11 100cc Syringe, Luer-Locking, 5-Pack
• 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: 2023-10-16Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite
• 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