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) (9) Filter, bacterial, breathing-circuit (CAH) (1)

Premarket Exempt

No Yes

Clear

ADULT ULTRA FLEX® - 00612649215648 Catalog Number : J6903F-13221Z

Device Description : ADULT ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

UNIVERSAL F® Flex - 00612649215662 Catalog Number : F92101

Device Description : UNIVERSAL F FLEX CIRCUIT PACK KIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

ADULT ULTRA FLEX® - 00612649215686 Catalog Number : F92102

Device Description : ADULT ULTRA FLEX CIRCUIT PACK KIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

VIROBAC II® - 00612649215709 Catalog Number : 342077

Device Description : VII VIRAL/BACTERIAL FILTER - Distributed by Philips

Device Class : 2

Duns Number: 009299017

Premarket Exempt : No

Product Code : CAH

Prescription Use : Yes

Device Count : 1

ADULT ULTRA FLEX® - 00612649215778 Catalog Number : J61213F-13621Z

Device Description : ADULT ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

UNIVERSAL F® FLEX2® - 00612649215884 Catalog Number : AF4110-6121Z

Device Description : UNIVERSAL F FLEX2 CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

NITRIC OXIDE - 00612649215907 Catalog Number : NO-1202

Device Description : NITRO OXIDE DELIVERY CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

UNIVERSAL F® FLEX2® - 00612649215921 Catalog Number : SJDF3115-6121Z

Device Description : UNIVERSAL FLEX2 CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

ADULT ULTRA FLEX® - 00612649215945 Catalog Number : GH61213F-6121Z

Device Description : ADULT ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

ADULT ULTRA FLEX® - 00612649215969 Catalog Number : 81214F-19121Z

Device Description : ADULT ULTRAFLEX CIRCUIT

Device Class : 1

Duns Number: 009299017

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : Yes

Device Count : 1

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