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) (8) Mouthpiece, Breathing (BYP) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

Yes No

Clear

N/A - 00850022357411 Catalog Number :

Device Description : Fuse, Holder for the Xenon Administration System

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Aero/Vent Plus, Aero/Vent Max - 00850022357428 Catalog Number :

Device Description : Aero/Vent Shield Base, Standoff with Mounting Attachments for Aero/Vent (Plus & Aero/Vent Shield Base, Standoff with Mounting Attachments for Aero/Vent (Plus & Max) Portable Shield, Aluminum Case & Aero/Vent Jr Portable Shield Aluminum Case.

Device Class : 2

Duns Number: 079628327

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357596 Catalog Number :

Device Description : Xenon Administration Set: Air Cushion Face Mask, Direct Dose Administration Adap Xenon Administration Set: Air Cushion Face Mask, Direct Dose Administration Adapter with Injection site, Ultra-Flex tubing (extends 6-24 inches), Bacterial/Viral Filter and 22mm Adapter

Device Class :

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357602 Catalog Number :

Device Description : Xenon Administration Set: Air Cushion Face Mask with Injection Port, Ultra-Flex Xenon Administration Set: Air Cushion Face Mask with Injection Port, Ultra-Flex tubing (extends 6-24 inches), Bacterial/Viral Filter and 22 mm Adapter

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357626 Catalog Number :

Device Description : Xenon Administration Set: Air Cushion Face Mask with Direct Dose Luer Lock, Ultr Xenon Administration Set: Air Cushion Face Mask with Direct Dose Luer Lock, Ultra-Flex tubing (extends 6-24 inches), Bacterial/Viral Filter and 22 mm Adapter

Device Class :

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357640 Catalog Number :

Device Description : Xenon Administration Set: Air Cushion Face Mask, Direct Dose Administration Ada Xenon Administration Set: Air Cushion Face Mask, Direct Dose Administration Adapter with Injection Site, 2 HEPA Filters, Ultra-Flex tubing (extends 6-24 inches) and 22 mm Adapter

Device Class :

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Xenon Master Administration Set - 00850022357664 Catalog Number :

Device Description : Air Cushion Face Mask 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 - 00850022357688 Catalog Number :

Device Description : Air Cushion Face Mask with direct dose luer lock.

Device Class : 2

Duns Number: 079628327

Premarket Exempt : Yes

Product Code : IYT

Prescription Use : Yes

Device Count : 1

Insta/Vent - Safe-T-Shield Mouthpiece - 00850022357701 Catalog Number :

Device Description : Safety Shield Mouthpiece with protective cap and Nose Clip.

Device Class : 1

Duns Number: 079628327

Premarket Exempt : No

Product Code : BYP

Prescription Use : Yes

Device Count : 1

Healthline, Medicator - 00850022357725 Catalog Number :

Device Description : Convenience Kit: Portless Vinyl Mask (Adult) with Adapter (HL-22), Bacterial/Vi Convenience Kit: Portless Vinyl Mask (Adult) 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

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