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

Circuit, breathing (w connector, adaptor, y piece) (CAI) (6) System, rebreathing, radionuclide (IYT) (4)

Premarket Exempt

No Yes

Clear

DISPOSABLE XENON CIRCUITFOR NUCLEAR MEDICINE - 00612649185798 Catalog Number : 21125

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 - 00612649185804 Catalog Number : 21126

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 - 00612649185811 Catalog Number : 21127

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 - 00612649185828 Catalog Number : 21129

Device Description : XENON CIRCUIT

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : IYT

Prescription Use : Yes

Device Count : 1

PEDIATRIC ULTRA FLEX® - 00612649185859 Catalog Number : 21212P-61

Device Description : PEDIATRIC ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

PEDIATRIC ULTRA FLEX® - 00612649185873 Catalog Number : 21212Y-6121

Device Description : PEDIATRIC ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT - 00612649185880 Catalog Number : 21214-136

Device Description : PEDIATRIC ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT - 00612649185897 Catalog Number : 21214-13621

Device Description : PEDIATRIC ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT - 00612649185903 Catalog Number : 21214-440

Device Description : PEDIATRIC ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

PEDIATRIC ULTRA FLEX®ANESTHESIA BREATHING CIRCUIT - 00612649185927 Catalog Number : 21216-6821Z

Device Description : PEDIATRIC ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

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