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, Anorectal Motility, And Tube (KLA) (10) Device, Biofeedback (HCC) (1)

Premarket Exempt

No Yes

Clear

mcompass Biofeedback Manometry Software - 00851607003211 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Commode - 00851607003228 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

LED Monitor - 00851607003235 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Syringe, Luer, 140cc, 5-pack - 00851607003242 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Syringe, Luer, 5cc, 5-pack - 00851607003259 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Syringe, Luer, 60cc, 5-pack - 00851607003266 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

mcompass ARM and BIofeedback System - 00851607003273 Catalog Number :

Device Description : Medspira Anorectal Manometry and Biofeedback System

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA, HCC

Prescription Use : No

Device Count : 1

Medspira mcompass Anorectal Manometry Tablet PC, w Dock, w Power Cord - 00851607003280 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Syringe, Luer, 200cc, 5-pack - 00851607003297 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply - 00851607003310 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

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