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

GUDID 00851607003334

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

MEDSPIRA, LLC

Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon Rectosphincteric balloon 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

• 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
• 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