Medi/Nuclear Corporation, Inc.

Address:4610 LITTLEJOHN ST.,BALDWIN PARK,CA,91706,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

System, Rebreathing, Radionuclide (IYT) (7) Absorbent, Carbon-Dioxide (CBL) (2) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

Healtline Medical - Medicator Redineb Drug Delivery System - 00850022357107 Catalog Number :

Device Description : Bracket, Pole Mount for (Insta/Vent or Medicator)

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357114 Catalog Number :

Device Description : Xenon Administration Set: Face Mask, Air-Filled with injection port

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357121 Catalog Number :

Device Description : Xenon Administration Set: Face Mask, injection port and 2 HEPA Filters

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357138 Catalog Number :

Device Description : Xenon Administration Set: Tube, HEPA Filter and face mask with adapter

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

N/A - 00850022357145 Catalog Number :

Device Description : Carbolyme, Co2 Absorbent approx weight 2.6 Lbs (1.18 kg) for Xenon Administration System

Device Class : 1

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : CBL

Prescription Use : Yes

Device Count : 1

N/A - 00850022357152 Catalog Number :

Device Description : Soda Lime, Plastic Container, 1 Lb for Xenon Administration System

Device Class : 1

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : CBL

Prescription Use : Yes

Device Count : 1

N/A - 00850022357169 Catalog Number :

Device Description : Drierite, Plastic Container, 1 Lb for Xenon Administration System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

N/A - 00850022357176 Catalog Number :

Device Description : Drierite, Plastic Container, 4.5 Lb for Xenon Administration System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Insta/Vent - Lung Ventilation Accessories - 00850022357183 Catalog Number :

Device Description : Mouthpiece Safe T Shield w/ 22mm adapter & 22mm flexible tubing (extends 6-24 inches)

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Insta/Vent - Lung Ventilation Accessories - 00850022357190 Catalog Number :

Device Description : Mouthpiece, Rigid

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

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