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

Device, Biofeedback (HCC) (6) Monitor, Esophageal Motility, Anorectal Motility, And Tube (KLA) (4) Monitor, Esophageal Motility, And Tube (KLA) (1)

Premarket Exempt

No Yes

Clear

Assy, 25' Pulmo Chest Bellows - 00851607003112 Catalog Number :

Device Description : Assy, 25' Pulmo Chest Bellows

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : HCC

Prescription Use : No

Device Count : 1

Monitor System, Patient Display - 00851607003129 Catalog Number :

Device Description : Interactive Breath Hold - Monitor System, Patient Display

Device Class : 2

Duns Number: 962187964

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Monitor System, IBC Base Unit - 00851607003136 Catalog Number :

Device Description : Interactive Breath Hold - Monitor System, IBC Base Unit

Device Class : 2

Duns Number: 962187964

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Switch, Inline Flow Control, Female Luer Inlet, Male Luer Outlet, 5-pack - 00851607003143 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

Monitor System, US Power Cord & Convertor - 00851607003150 Catalog Number :

Device Description : Interactive Breath Hold - Monitor System, US Power Cord & Convertor

Device Class : 2

Duns Number: 962187964

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : No

Device Count : 1

Assy, Philips 23' Pulmo Chest Bellows, Tubing ES - 00851607003167 Catalog Number :

Device Description : Custom Assembly. Philips 23" Pulmo Chest Bellows, Tubing ES

Device Class :

Duns Number: 962187964

Premarket Exempt : Yes

Product Code : HCC

Prescription Use : Yes

Device Count : 1

VGA Cable - 00851607003174 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

mcompass Extension Tube Set - 00851607003181 Catalog Number : RMD-002-006

Device Description : Medspira mcompass Extension Tube Set

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA, HCC

Prescription Use : Yes

Device Count : 1

mcompass Petite Anorectal Manometry 5-Channel Catheter - 00851607003198 Catalog Number :

Device Class :

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

mcompass Anorectal Manometry Software - 00851607003204 Catalog Number :

Device Class : 2

Duns Number: 962187964

Premarket Exempt : No

Product Code : KLA

Prescription Use : Yes

Device Count : 1

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