FDA.reportPublic FDA data

System, mcompass®, Anorectal Manometry

Primary DI
10851607003454
Brand
System, mcompass®, Anorectal Manometry
Company
MEDSPIRA, LLC
Model
RMD-201
Device description
System, mcompass®, Anorectal Manometry
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLAMonitor, Esophageal Motility, Anorectal Motility, And Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851607003454PackageGS15In Commercial Distribution
00851607003457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085160700345410851607003454
00851607003457008516070034578516070034570851607003457

GMDN Terms#

Term, Definition table
TermDefinition
Manometric gastrointestinal motility analysis systemAn assembly of devices which includes a main computerized unit designed to evaluate peristaltic motility in the gastrointestinal tract by measuring pressure using an intraluminal sensor catheter/probe at several points; it may also measure pH, respiration, and swallowing with appropriate sensors. In addition to the central computer with software it may includethe appropriate perfusion and/or nonperfusion catheters. It is intended to evaluate patients with dysphagia, gastro-oesophageal reflux disease (GERD), noncardiac chest pain, and/or assess connective tissue and neuromuscular disease.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Product should be kept dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
612-789-0013info@medspira.com

Regulatory Flags#

DUNS number
962187964
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851607003501mcompass Anorectal Balloon Expulsion CatheterRMD-003-001RMD-003-0012025-12-30
00851607003006QuikLinq FOB Adapter RMD-210-0202025-03-10
10851607003003QuikLinq FOB Adapter RMD-210-0202025-03-10
008516070035325-Pack, Luer-Locking, 100cc SyringeRMD-010-0172025-03-03
108516070035395-Pack, Luer-Locking, 100cc SyringeRMD-010-0172025-03-03
008516070035185-Pack, 100 cc Syringe, Luer-lockingRMD-010-0162024-12-20
108516070035155-Pack, 100 cc Syringe, Luer-lockingRMD-010-0162024-12-20
00851607003389System Accessory KitRMD-010-0112024-11-30
10851607003386System Accessory KitRMD-010-0112024-11-30
00851607003525Battery, Tablet PCRMD-010-0092024-11-30
00851607003235LED MonitorRMD-002-MON2021-07-01
00851607003341Single Patient Kit, mcompass, Anorectal Manometry 2-channelRMD-002-0112023-10-06
00851607003372Medspira Tablet PC with Power SupplyRMD-010-0102023-10-06
00851607003396mcompass Anorectal Manometry SystemRMD-001U2023-10-06
00851607003419Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-packRMD-202-0072023-10-06
00851607003426Catheter, mcompass®, Biofeedback, 2-channel, 5-packRMD-202-0042023-10-06
00851607003433Extension Tube, mcompass® Catheter, 5-packRMD-202-0062023-10-06
00851607003440Extension Tube, mcompass® Catheter, 5-packRMD-201-0012023-10-06
00851607003457System, mcompass®, Anorectal Manometry RMD-2012023-10-06
00851607003464System, mcompass®, Anorectal Manometry RMD-201U2023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00678467508409Mui ScientificH & A Mui Enterprises IncKLA2025-11-17
00678467508225Mui ScientificH & A Mui Enterprises IncKLA2025-04-07
00851607003006QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
10851607003003QuikLinq FOB Adapter MEDSPIRA, LLCKLA2025-03-10
00627825014830SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
00627825014823SOLAR Anorectal Manometry ChargerLaborie Medical Technologies Corp.KLA2025-03-06
10627825014837SOLAR Anorectal Manometry CatheterLaborie Medical Technologies Corp.KLA2025-03-06
008516070035325-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
108516070035395-Pack, Luer-Locking, 100cc SyringeMEDSPIRA, LLCKLA2025-03-03
00678467508201Mui ScientificH & A Mui Enterprises IncKLA2025-02-20
68051887046715THD Procto Software SystemTHD SPAKLA2025-02-20
B960RED201REDNeuraxis, Inc.KLA2025-01-09
008516070035185-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
108516070035155-Pack, 100 cc Syringe, Luer-lockingMEDSPIRA, LLCKLA2024-12-20
00851607003389System Accessory KitMEDSPIRA, LLCKLA2024-11-30
10851607003386System Accessory KitMEDSPIRA, LLCKLA2024-11-30
00851607003525Battery, Tablet PCMEDSPIRA, LLCKLA2024-11-30
00678467508157Mui ScientificH & A Mui Enterprises IncKLA2024-10-11
00678467508140Mui ScientificH & A Mui Enterprises IncKLA2024-07-03
00678467508133Mui ScientificH & A Mui Enterprises IncKLA2024-06-21
00678467508089Mui ScientificH & A Mui Enterprises IncKLA2024-04-16
00678467508096Mui ScientificH & A Mui Enterprises IncKLA2024-04-16
00678467508072Mui ScientificH & A Mui Enterprises IncKLA2024-03-21
68051887043295THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043301THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043318THD Procto Software SystemTHD SPAKLA2023-12-14
68051887043325THD Procto Software SystemTHD SPAKLA2023-12-14
00851607003341Single Patient Kit, mcompass, Anorectal Manometry 2-channelMEDSPIRA, LLCKLA2023-10-06
00851607003372Medspira Tablet PC with Power SupplyMEDSPIRA, LLCKLA2023-10-06
00851607003396mcompass Anorectal Manometry SystemMEDSPIRA, LLCKLA2023-10-06