MEDSPIRA, LLC

Address:2718 Summer St NE,Minneapolis,MN,55413,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Monitor, Esophageal Motility, And Tube (KLA) (5) Device, Biofeedback (HCC) (4) Coil, Magnetic Resonance, Specialty (MOS) (2) Monitor, Esophageal Motility, Anorectal Motility, And Tube (KLA) (1)

Premarket Exempt

No Yes

Clear

1.5T BC-10 Transmit/Receive MRI Coil - 00851607003013 Catalog Number : 42T9165

Device Description : Medspira 1.5T BC-10 Transmit/Receive MRI Coil

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

3.0T BC-10 Transmit/Receive MRI Coil - 00851607003020 Catalog Number : 42T9170

Device Description : Medspira 3.0T BC-10 Transmit/Receive MRI Coil

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : MOS

Prescription Use : No

Device Count : 1

mcompass Anorectal Manometry Catheter - 00851607003037 Catalog Number : RMD-002-003

Device Description : Medspira mcompass 5 Channel Anorectal Manometry Catheter

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : No

Device Count : 1

mcompass Anorectal Manometry FOB - 00851607003044 Catalog Number : RMD-001-001

Device Description : Medspira mcompass Anorectal Manometry FOB

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : No

Device Count : 1

mcompass Anorectal Manometry System - 00851607003051 Catalog Number : RMD-001

Device Description : Medspira mcompass Diagnostic Anorectal Manometry system

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : No

Device Count : 1

mcompass Biofeedback Manometry System - 00851607003068 Catalog Number : RMD-002

Device Description : Medspira Biofeedback Anorectal Manometry System

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA, HCC

Prescription Use : No

Device Count : 1

mcompass Biofeedback 2-Channel Catheter - 00851607003075 Catalog Number : RMD-002-004

Device Description : Medspira mcompass Biofeedback 2-Channel Anorectal Manomtery Catheter

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA, HCC

Prescription Use : No

Device Count : 1

Interactive Breath Hold Monitor - 00851607003082 Catalog Number : 43T0970

Device Description : Interactive Breath Hold Monitor

Device Class : 2

Duns Number: 962187964

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Pouch with Strap for mcompass® FOB - 00851607003099 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Assy, Pulmo Chest Bellows, Tubing - 00851607003105 Catalog Number :

Device Description : Interactive Breath Hold Monitor - Assy, Pulmo Chest Bellows, Tubing 10'

Device Class :

Duns Number: 962187964

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

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