FDA.reportPublic FDA data

mcompass Anorectal Balloon Expulsion Catheter

Primary DI
00851607003501
Brand
mcompass Anorectal Balloon Expulsion Catheter
Company
MEDSPIRA, LLC
Model
RMD-003-001
Catalog number
RMD-003-001
Device description
mcompass Anorectal Balloon Expulsion Catheter
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFXSystem, Gastrointestinal Motility (Electrical)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFXSystem, Gastrointestinal Motility (Electrical)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252605000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252605000mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLC2025-12-05FFX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10851607003508PackageGS15In Commercial Distribution
00851607003501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085160700350810851607003508
00851607003501008516070035018516070035010851607003501

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
612-789-0013Support@medspira.com

Regulatory Flags#

DUNS number
962187964
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00851607003471System, mcompass®, Biofeedback TherapyRMD-2022023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10678467508437Mui ScientificH & A Mui Enterprises IncFFX2026-04-15
10678467508413Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00678467508416Mui ScientificH & A Mui Enterprises IncFFX2026-01-23
00678467508393Mui ScientificH & A Mui Enterprises IncFFX2025-11-04
00678467508386Mui ScientificH & A Mui Enterprises IncFFX2025-10-21
00678467508362Mui ScientificH & A Mui Enterprises IncFFX2025-09-15
10678467508352Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
00678467508355Mui ScientificH & A Mui Enterprises IncFFX2025-08-28
10678467508345Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
00678467508348Mui ScientificH & A Mui Enterprises IncFFX2025-08-26
10678467508338Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
00678467508331Mui ScientificH & A Mui Enterprises IncFFX2025-08-21
10884521855441ManoScanGiven Imaging, Inc.FFX2025-08-21
10678467508307Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508314Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508300Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
00678467508317Mui ScientificH & A Mui Enterprises IncFFX2025-07-22
10678467508109Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
10678467508291Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508102Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508294Mui ScientificH & A Mui Enterprises IncFFX2025-07-03
00678467508270Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00678467508287Mui ScientificH & A Mui Enterprises IncFFX2025-06-11
00816734023433Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023440Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023457Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023464Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023471Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
00816734023488Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.FFX2025-05-16
10678467508253Mui ScientificH & A Mui Enterprises IncFFX2025-04-15