BIONIX DEVELOPMENT CORPORATION

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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

TUBES, GASTROINTESTINAL (AND ACCESSORIES) (KNT) (8) blanket, neonatal phototherapy (PDH) (2)

Premarket Exempt

No Yes

Clear

BIONIX DEVELOPMENT CORPORATION - 08599110040089 Catalog Number : 913

Device Description : DeClogger 20-22 F/Green

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 08599110040096 Catalog Number : 921

Device Description : DeClogger 14-16 F/Brown

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 08599110040102 Catalog Number : 922

Device Description : DeClogger 18-24 F/Orange

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 08599110040133 Catalog Number : 1100

Device Description : Swaddler for PhotoTherapy, preemie

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : PDH

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 08599110040140 Catalog Number : 1105

Device Description : Swaddler for PhotoTherapy, normal

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : PDH

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 10859911004228 Catalog Number : 911

Device Description : DeClogger 14-16 F/Blue

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 10859911004235 Catalog Number : 912

Device Description : DeClogger 16-18 F/Yellow

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 10859911004242 Catalog Number : 913

Device Description : DeClogger 20-22 F/Green

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 10859911004259 Catalog Number : 921

Device Description : DeClogger 14-16 F/Brown

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

BIONIX DEVELOPMENT CORPORATION - 10859911004266 Catalog Number : 922

Device Description : DeClogger 18-24 F/Orange

Device Class : 2

Duns Number: 602736795

Premarket Exempt : No

Product Code : KNT

Prescription Use : No

Device Count : 1

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