FDA.reportPublic FDA data

mcompass Biofeedback Manometry System

Primary DI
00851607003068
Brand
mcompass Biofeedback Manometry System
Company
MEDSPIRA, LLC
Model
RMD-002
Catalog number
RMD-002
Device description
Medspira Biofeedback Anorectal Manometry System
Published
2017-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
KLAMonitor, Esophageal Motility, And Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
KLAMonitor, Esophageal Motility, Anorectal Motility, And TubeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143031000mcompass Biofeedback Anorectal Manometry SystemMedspira, LLC2015-07-07KLA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851607003065PackageGS11In Commercial Distribution
00851607003068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085160700306510851607003065
00851607003068008516070030688516070030680851607003068

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.

Contacts#

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

Regulatory Flags#

DUNS number
962187964
Device count
1

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

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