INSTRUMENTATION INDUSTRIES, INCORPORATED

Address:2990 INDUSTRIAL BLVD,BETHEL PARK,PA,15102,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) (3) Connector, Airway (Extension) (BZA) (3) Support, Breathing Tube (JAY) (3) Tubing, Pressure And Accessories (BYX) (1)

Premarket Exempt

No Yes

Clear

BE 105-2222 Swivel Adapter - M996BE1052220 Catalog Number : BE 105-2222

Device Description : Swivel Adapter 22mm ID x 15mm ID/22mm OD. Specialty adapter for ventilator circu Swivel Adapter 22mm ID x 15mm ID/22mm OD. Specialty adapter for ventilator circuits/CPAP systems. Swivels 360 degrees. Molded of polypropylene. Single Patient Use.

Device Class :

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 105-2X22 Adapter - M996BE1052X220 Catalog Number : BE 105-2X22

Device Description : General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circ General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circuit. Molded of polycarbonate. Reusable.

Device Class :

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 105-2X22D Adapter - M996BE1052X22D0 Catalog Number : BE 105-2X22D

Device Class :

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 105-40 Pressure Adapter - M996BE105400 Catalog Number : BE 105-40

Device Description : The BE 105-40 Pressure Adapter: Dimensions - Barbed port fits 3/16" I.D. tubing The BE 105-40 Pressure Adapter: Dimensions - Barbed port fits 3/16" I.D. tubing, x 15mm I.D./22mm O.D. x 15mm I.D./22mm O.D. Barbed port is capped with a silicone rubber cap.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : No

Device Count : 1

BE 105-7 Bronchoscope Swivel - M996BE10570 Catalog Number : BE 105-7

Device Description : BE 105-7 Bronchoscope Swivel - 15mm ID (patient port) x15mm OD (equipment port). BE 105-7 Bronchoscope Swivel - 15mm ID (patient port) x15mm OD (equipment port). Reusable. Fits components of adult ventilator circuits. Molded of polyetherimide. Includes two silicone rubber caps; one cap allows for the use of a suctioning catheter while the other cap allows for the use of a fiber-optic bronchoscope without significant loss of PEEP.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

BE 105-8 Bronchoscope Swivel - M996BE10580 Catalog Number : BE 105-8

Device Description : BE 105-8 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x15mm OD (equipmen BE 105-8 Bronchoscope Swivel - 15mm ID/22mm OD (patient port) x15mm OD (equipment port). Reusable. Fits components of adult ventilator circuits. Molded of polyetherimide. Includes two silicone rubber caps; one cap allows for the use of a suctioning catheter while the other cap allows for the use of a fiber-optic bronchoscope without significant loss of PEEP.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

BE 106 Adult Adapter with Vent - M996BE1060 Catalog Number : BE 106

Device Description : Specialty Adapter with Vent - 15mm ID/22mm OD/15mm ID/22mm OD. Fits components o Specialty Adapter with Vent - 15mm ID/22mm OD/15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : BZA

Prescription Use : No

Device Count : 1

BE 114-1 Flexible Support Arm Pole Bracket - M996BE11410 Catalog Number : BE 114-1

Device Description : The BE 114-1 Flexible Support Arm Pole Bracket permits mounting of "Flexible Sup The BE 114-1 Flexible Support Arm Pole Bracket permits mounting of "Flexible Support Arms" to poles up to 1" in diameter. Components and materials: bracket body: anodized aluminum; screw: steel with phenolic handle. Made in the USA.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : No

Device Count : 1

BE 114-2 Flexible Support Arm Pole Bracket - M996BE11420 Catalog Number : BE 114-2

Device Description : The BE 114-2 Flexible Support Arm Pole Bracket permits mounting of "Flexible Sup The BE 114-2 Flexible Support Arm Pole Bracket permits mounting of "Flexible Support Arms" to poles up to 1.5" in diameter. Components and materials: bracket body: anodized aluminum; screw: steel with phenolic handle. Made in the USA.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : No

Device Count : 1

BE 114-5 Flexible Support Arm Universal Rail Mount Bracket - M996BE11450 Catalog Number : BE 114-5

Device Description : The BE 114-5 Flexible Support Arm Universal Rail Mount Bracket permits rail moun The BE 114-5 Flexible Support Arm Universal Rail Mount Bracket permits rail mounting of "Flexible Support Arms". The BE 114-5 is not compatible with rails mounted flush to wall. Components and materials: bracket body: anodized aluminum; screw: steel with phenolic knob. Made in the USA.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : JAY

Prescription Use : No

Device Count : 1

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