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MEDSPIRA LLC

Last updated September 17, 2026

What MEDSPIRA LLC makes

Medspira LLC manufactures gastrointestinal motility analysis systems, including anorectal manometry devices and associated software for diagnostic assessment. Their portfolio also includes breath-hold systems—comprising patient belts, remote displays, and base stations—to aid in MRI imaging by reducing motion artifacts. Additional products include rectosphincteric balloons for medical testing and radio-frequency coils for MRI systems. Accessories like syringes, cables, and commodes are also part of their offerings.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Medspira LLC operates from the United States, adhering to applicable U.S. medical device compliance requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: 2718 Summer St NE, Minneapolis, MN, 55413
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008414621
DUNS Number: —

Catalogue (54)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
5-Pack, Luer-Locking, 100cc Syringe	RMD-010-017	FDA UDI	Class II	Active
LED Monitor	RMD-002-MON	FDA UDI	Class II	Active
Syringe, Luer, 5cc, 5-pack	RMD-010-006	FDA UDI	Class II	Active
Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply	RMD-010-004	FDA UDI	Class II	Active
AC Power Cable	RMD-010-003	FDA UDI	Class II	Active
Assy, Pulmo Chest Bellows, Tubing	A01A103	FDA UDI	Class II	Active
mcompass Anorectal Manometry System	RMD-001U	FDA UDI	Class II	Active
System, mcompass®, ARM + Biofeedback	RMD-203	FDA UDI	Class II	Active
mcompass Anorectal Manometry System	RMD-001	FDA UDI	Class II	Active
Commode	RMD-002-COM	FDA UDI	Class II	Active
VGA Cable	RMD-002-VGA	FDA UDI	Class II	Active
mcompass Biofeedback Manometry Software	RMD-002-001	FDA UDI	Class II	Active
Monitor System, US Power Cord & Convertor	M43T1071	FDA UDI	Class II	Active
Pouch with Strap for mcompass® FOB	RMD-002-POUCH	FDA UDI	Class II	Active
mcompass Biofeedback Manometry System	RMD-002	FDA UDI	Class II	Active
mcompass Petite Anorectal Manometry 5-Channel Catheter	RMD-002-007	FDA UDI	Class II	Active
mcompass Extension Tube Set	RMD-002-006	FDA UDI	Class II	Active
System, mcompass®, Anorectal Manometry	RMD-201	FDA UDI	Class II	Active
5-Pack, 100 cc Syringe, Luer-locking	RMD-010-016	FDA UDI	Class II	Active
System, mcompass®, Anorectal Manometry	RMD-201U	FDA UDI	Class II	Active
mcompass Biofeedback 2-Channel Catheter	RMD-002-004	FDA UDI	Class II	Active
Battery, FOB	RMD-010-009	FDA UDI	Class II	Active
Monitor System, Patient Display	43T2564	FDA UDI	Class II	Active
Monitor System, IBC Base Unit	43T2631	FDA UDI	Class II	Active
Syringe, Luer, 200cc, 5-pack	RMD-010-008	FDA UDI	Class II	Active
Interactive Breath Hold Monitor	IBC01	FDA UDI	Class II	Active
Battery, Tablet PC	RMD-010-009	FDA UDI	Class II	Active
mcompass Anorectal Manometry Software	RMD-001-003	FDA UDI	Class II	Active
mcompass ARM and BIofeedback System	RMD-003	FDA UDI	Class II	Active
Extension Tube, mcompass® Catheter, 5-pack	RMD-202-006	FDA UDI	Class II	Active
System Accessory Kit	RMD-010-011	FDA UDI	Class II	Active
mcompass Anorectal Manometry Catheter	RMD-002-003	FDA UDI	Class II	Active
Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack	RMD-202-007	FDA UDI	Class II	Active
mcompass Anorectal Manometry FOB	RMD-001-001	FDA UDI	Class II	Active
Switch, Inline Flow Control, Female Luer Inlet, Male Luer Outlet, 5-pack	RMD-010-001	FDA UDI	Class II	Active
System, mcompass®, Biofeedback Therapy	RMD-202	FDA UDI	Class II	Active
Single Patient Kit, mcompass, Anorectal Manometry 2-channel	RMD-002-011	FDA UDI	Class II	Active
Catheter, mcompass®, Anorectal Manometry 5-channel, 5-pack	RMD-202-003	FDA UDI	Class II	Active
Extension Tube, mcompass® Catheter, 5-pack	RMD-201-001	FDA UDI	Class II	Active
Medspira mcompass Anorectal Manometry Tablet PC, w Dock, w Power Cord	RMD-001-TAB	FDA UDI	Class II	Active
Syringe, Luer, 140cc, 5-pack	RMD-010-005	FDA UDI	Class II	Active
Assy, 25' Pulmo Chest Bellows	A01A103LONG	FDA UDI	Class II	Active
Syringe, Luer, 60cc, 5-pack	RMD-010-007	FDA UDI	Class II	Active
Single Patient Kit, mcompass, Anorectal Manometry 5-channel	RMD-002-009	FDA UDI	Class II	Active
3.0T BC-10 Transmit/Receive MRI Coil	42T9170	FDA UDI	Class II	Active
Catheter, mcompass®, Biofeedback, 2-channel, 5-pack	RMD-202-004	FDA UDI	Class II	Active
Single Patient Kit, mcompass, Anorectal Manometry 5-channel, Petite	RMD-002-010	FDA UDI	Class II	Active
1.5T BC-10 Transmit/Receive MRI Coil	42T9165	FDA UDI	Class II	Active
QuikLinq FOB Adapter	RMD-210-020	FDA UDI	Class II	Active
Medspira Tablet PC with Power Supply	RMD-010-010	FDA UDI	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Medspira LLC has one FDA recall record initiated on June 14, 2017, which is recorded as terminated. The recall was due to a potential failure in the balloon bond of the inner catheter stem, which could result in the balloon separating from the inner stem and remaining in the rectal cavity.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Jun 14, 2017	Z-3072-2017	—	terminated	Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.