Innovative Med

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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

Accessories, Catheter (KGZ) (6) Cannula, Surgical, General & Plastic Surgery (GEA) (3) Dissector, Surgical, General & Plastic Surgery (GDI) (1)

Premarket Exempt

No Yes

Clear

KMI IMI GROUP - 00851314007106 Catalog Number :

Device Description : Infiltration Cannula

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007113 Catalog Number :

Device Description : Handles & Adaptors

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007120 Catalog Number :

Device Description : Dissectors & Disruptors

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : GDI

Prescription Use : Yes

Device Count : 1

Micro Injection Needle - 00851314007137 Catalog Number :

Device Description : Micro Injection Needle

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007144 Catalog Number : IM-AFTD

Device Description : Infiltration Pump Tubing

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007151 Catalog Number : IM-RIKD

Device Description : Repetitive Injection Kit

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007168 Catalog Number : IM-ITD

Device Description : Manual infusion tubing w/ Luer Lock & IV Bag Spike

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007175 Catalog Number : IM-AFTDY

Device Description : Infusion Pump tubing w/ Double Spike Wye

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007182 Catalog Number : IM-HFTD

Device Description : Suction Tubing

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

KMI IMI GROUP - 00851314007199 Catalog Number :

Device Description : Disposable Infiltration Kit

Device Class : 1

Duns Number: 928308407

Premarket Exempt : Yes

Product Code : KGZ

Prescription Use : Yes

Device Count : 1

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