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

Shield, Protective, Personnel (KPY) (4) Shield, Vial (IWW) (2) System, Rebreathing, Radionuclide (IYT) (2) Nebulizer (Direct Patient Interface) (CAF) (1) Stretcher, Wheeled (FPO) (1)

Premarket Exempt

No Yes

Clear

MRI Stretcher Fowler Back - 00718175001103 Catalog Number : 240-110

Device Description : Stretcher, Fowler Back, MRI

Device Class : 2

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : FPO

Prescription Use : No

Device Count : 1

Aerotech I Radioaerosol Administration System - 00718175001240 Catalog Number : 177-124

Device Description : Aerotech I Radioaerosol Administration System

Device Class :

Duns Number: 043833813

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

Xenon Rebreathing System - 00718175001332 Catalog Number : 060-133

Device Description : Disposable Xenon-133 Rebreathing System

Device Class :

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : No

Device Count : 1

Xenon Rebreathing System - 00718175001370 Catalog Number : 060-137

Device Description : Disposable Xenon Rebreathing System

Device Class :

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : No

Device Count : 1

PET VIAL PIG - 00718175001707 Catalog Number : 001-706

Device Description : Pig, Vial, PET, 10/30 ml, 1" lead for 30 ml vials

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWW

Prescription Use : No

Device Count : 1

INTEGO - 00718175001714 Catalog Number : 001-708

Device Description : Shield, Vial, Tungsten for 30 ml for Hospira vials. Includes lifting handle

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : IWW

Prescription Use : No

Device Count : 1

INTEGO - 00718175001721 Catalog Number : 001-723

Device Description : Shipping Container, Intego

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

PET SHIPPING SYSTEM - 00718175001738 Catalog Number : 001-724

Device Description : Shipping System, PET, Vial for 10 or 30 ml vials

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

PET SHIPPING SYSTEM - 00718175001745 Catalog Number : 001-739

Device Description : Shipping System, PET, Triple Dose for three single Unit Dose Pigs.

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

PET UNIT DOSE - 00718175001752 Catalog Number : 001-785

Device Description : Pig, Unit Dose, PET, 3/5 cc, .5" lead accommodates syringes with or without needle

Device Class : 1

Duns Number: 043833813

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

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