Medi/Nuclear Corporation, Inc.

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

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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) (9) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

Yes No

Clear

Healthline, Medicator - 00850022357749 Catalog Number :

Device Description : Convenience Kit: Portless Vinyl Mask (Pediatric) with Adapter (HL-22), Bacteria Convenience Kit: Portless Vinyl Mask (Pediatric) with Adapter (HL-22), Bacterial/Viral Filter, Ultra-Flex tubing (extends 6-24 inches), Aerosol Flow Tee, and End Cap.

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

Aero/Vent Jr. - 00857863007000 Catalog Number :

Device Description : Aero/Vent Jr. Radioaerosol Unit w/HEPA Filter, Two Tube System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Jr. - 00857863007017 Catalog Number :

Device Description : Aero/Vent Jr. Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, Two Aero/Vent Jr. Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, Two Tube System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Jr. - 00857863007024 Catalog Number :

Device Description : Aero/Vent Jr. w/HEPA Filter & Mask, Two Tube System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Jr. - 00857863007031 Catalog Number :

Device Description : Aero/Vent Jr. Ventilator Kit w/HEPA Filter, For ventilator dependent patients

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Plus - 00857863007048 Catalog Number :

Device Description : Aero/Vent Plus Radioaerosol Unit w/HEPA Filter

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Plus - 00857863007055 Catalog Number :

Device Description : Aero/Vent Plus w/HEPA Filter & Mask

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Plus - 00857863007062 Catalog Number :

Device Description : Aero/Vent Plus Ventilator Kit w/HEPA Filter, For ventilator dependent patients

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Plus - 00857863007079 Catalog Number :

Device Description : Aero/Vent Plus Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, and Aero/Vent Plus Radioaerosol Unit w/HEPA Filter and Safety Shield Mouthpiece, and bacteria filter optional

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Max - 00857863007086 Catalog Number :

Device Description : Aero/Vent Max Radioaerosol Unit w/HEPA Filter, Two Tube System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

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