KREG MEDICAL INC.

Address:1940 Janice Ave,Melrose Park,IL,60160,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

Mattress, Flotation Therapy, Non-Powered (IKY) (3) Cover, Mattress (Medical Purposes) (FMW) (2) Cushion, Flotation (KIC) (2) Bed, Ac-Powered Adjustable Hospital (FNL) (1) Bed, Patient Rotation, Powered (IKZ) (1) Mattress, Air Flotation, Alternating Pressure (FNM) (1)

Premarket Exempt

Yes

Clear

EZ WIDER, FOOT WIDTH EXTENSION - LH - 00850520008112 Catalog Number :

Device Description : Food Width Extension - LH

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

EZ WIDER, FOOT LENGTH EXTENSION - 00850520008129 Catalog Number :

Device Description : Food Length Extension

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : KIC

Prescription Use : No

Device Count : 1

CATALYST NON-EXPANDABLE BED - 00850520008143 Catalog Number :

Device Description : Hospital Bed with Standing Frame

Device Class : 2

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : FNL

Prescription Use : No

Device Count : 1

THE KREG INTEGRATED CLRT MATTRESS SYSTEM - 00850520008150 Catalog Number :

Device Description : Hospital Bed Surface

Device Class : 2

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : IKZ

Prescription Use : No

Device Count : 1

THE KREG INTEGRATED ALTERNATING MATTRESS SYSTEM - 00850520008167 Catalog Number :

Device Description : Hospital Bed Surface

Device Class : 2

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : FNM

Prescription Use : No

Device Count : 1

VISCO MEMORY FOAM MATTRESS ASSEMBLY - 00850520008174 Catalog Number :

Device Description : Hospital Bed Surface

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

COMPOSURE MATTRESS ASSEMBLY - 00850520008181 Catalog Number :

Device Description : Hospital Bed Surface

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

KREG AIR, STAGE IV, LOW AIR LOSS, L/P, EZ WIDER - 00850520008198 Catalog Number :

Device Description : Hospital Bed Surface

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : IKY

Prescription Use : No

Device Count : 1

COVERLET WITH ZIPPER - 00850520008204 Catalog Number :

Device Description : Deep Purple Coverlet with Zipper

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : No

Device Count : 1

COVERLET WITH ZIPPER - 00850520008211 Catalog Number :

Device Description : Silver Coverlet with Zipper

Device Class : 1

Duns Number: 079220324

Premarket Exempt : Yes

Product Code : FMW

Prescription Use : No

Device Count : 1

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