BIODEX MEDICAL SYSTEMS, INC.

Address:49 Natcon Drive,Shirley,NY,11967,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

Holder, Syringe, Lead (IWR) (6) Nebulizer (Direct Patient Interface) (CAF) (1) Shield, Protective, Personnel (KPY) (1) Shield, Vial (IWW) (1) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

No Yes

Clear

SHIELDED SYRINGE CARRIER - 00718175000779 Catalog Number : 001-180

Device Description : Syringe Carrier, Large, .25" Lead

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

SHIELDED SYRINGE CARRIERS - 00718175000786 Catalog Number : 001-181

Device Description : Syringe Carrier, Small, .125" Lead

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

SHIELDED SYRINGE CARRIERS - 00718175000793 Catalog Number : 001-182

Device Description : Syringe Carrier, Small, .25" Lead

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

VIAL SHIELD - 00718175000809 Catalog Number : 001-236

Device Description : Shield, Vial, 0.25" Lead

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWW

Prescription Use : No

Device Count : 1

PRO-TEC PIG - 00718175000816 Catalog Number : 001-280

Device Description : Pig, Pro-Tec, 3 / 6, Red

Device Class :

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

PRO-TEC PIG - 00718175000823 Catalog Number : 001-281

Device Description : Pig, Pro-Tec, 3/6cc, White

Device Class :

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

PRO-TEC PIG - 00718175000830 Catalog Number : 001-282

Device Description : Pig, Pro-Tech, 3/6cc Blue

Device Class :

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWR

Prescription Use : No

Device Count : 1

MRI Stretcher - 00718175001004 Catalog Number : 240-100

Device Description : Stretcher, MRI

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

SHIELDED WASTE CONTAINER - 00718175001066 Catalog Number : 039-106

Device Description : Waste Container, .125" Lead

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

Micro-Vent - 00718175001073 Catalog Number : 177-107

Device Description : Micro-Vent Radioaerosol System

Device Class :

Duns Number: 043833813

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

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