King Systems Corporation

Address:15011 HERRIMAN BLVD.,Noblesville,IN,46060,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) (4) SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) (BZO) (3) Circuit, breathing (w connector, adaptor, y piece) (CAI) (2) Filter, bacterial, breathing-circuit (CAH) (1)

Premarket Exempt

No Yes

Clear

RE'SPOSABLE® F2® CO-AXIAL - 00612649149110 Catalog Number : MD120

Device Description : RESPOSABLE F2 MANIFOLD & TUBING

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

UNIVERSAL F2®ANESTHESIA BREATHING CIRCUIT - 00612649184241 Catalog Number : D460-6133Z

Device Description : UNIVERSAL F2 CIRCUIT 20/CS

Device Class :

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 20

DISPOSABLE XENON KITFOR NUCLEAR MEDICINE - 00612649185279 Catalog Number : 20005

Device Description : XENON CIRCUIT

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

DISPOSABLE XENON KITFOR NUCLEAR MEDICINE - 00612649185293 Catalog Number : 20035

Device Description : XENON CIRCUT

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE - 00612649185330 Catalog Number : 20120

Device Description : XENON CIRCUIT

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE - 00612649185347 Catalog Number : 20125

Device Description : XENON CIRCUIT

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

VIROBAC II® FILTERKING SYSTEMS PART # 20801B - 00612649185408 Catalog Number : 203-310-004-G

Device Description : Note: 203-310-004-G is new part number for 203-310-004 REV G. Product did not change.

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

VENTILATOR CIRCUIT - 00612649185514 Catalog Number : 20725F-B

Device Description : VENTILATOR CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

VENTILATOR CIRCUIT - 00612649185521 Catalog Number : 20740F-A

Device Description : VENTILATOR CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

VENTILATOR CIRCUIT - 00612649185538 Catalog Number : 20740F-B

Device Description : VENTILATOR CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : Yes

Device Count : 1

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