INSTRUMENTATION INDUSTRIES, INCORPORATED

Address:2990 INDUSTRIAL BLVD,BETHEL PARK,PA,15102,US

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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) (7) Valve, Non-Rebreathing (CBP) (3)

Premarket Exempt

No Yes

Clear

BE 125-1 ReusableTee Adapter - M996BE12510 Catalog Number : BE 125-1

Device Description : The BE 125-1 Tee Adapter is intended for use in a ventilator, oxygen or BIPAP ci The BE 125-1 Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Dimensions: 22mm O.D. x 22mm O.D. x 15mm I.D./22mm O.D Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 125-1T ReusableTee Adapter - M996BE1251T0 Catalog Number : BE 125-1T

Device Description : The BE 125-1T Tee Adapter is intended for use in a ventilator, oxygen or BIPAP c The BE 125-1T Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D./22mm O.D Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 125-1TD Disposable Tee Adapter - M996BE1251TD0 Catalog Number : BE 125-1TD

Device Description : The BE 125-1TD Tee Adapter is intended for use in a ventilator, oxygen or BIPAP The BE 125-1TD Tee Adapter is intended for use in a ventilator, oxygen or BIPAP circuit. Can be used to easily add a monitoring device such as a temperature probe to the breathing circuit. Dimensions: 22mm O.D. x 22mm I.D. x 15mm I.D. Single Patient Use. Molded of High Density Polyethylene.

Device Class :

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 127 Wye Connector - M996BE1270 Catalog Number : BE 127

Device Description : BE 127 Wye Connector with (2) 22mm OD ports and (1) 15mm ID/22mm OD port. Fits c BE 127 Wye Connector with (2) 22mm OD ports and (1) 15mm ID/22mm OD port. Fits components of adult ventilator circuits. Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 127-40 Wye Connector - M996BE127400 Catalog Number : BE 127-40

Device Description : BE 127-40 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port and (1) BE 127-40 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port and (1) barbed pressure port. Fits components of adult ventilator circuits. Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 127-7.5 Wye Connector - M996BE127750 Catalog Number : BE 127-7.5

Device Description : BE 127-7.5 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port and 7. BE 127-7.5 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port and 7.5mm temperature probe port. Fits components of adult ventilator circuits. Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 127-7.5-40 Wye Connector - M996BE12775400 Catalog Number : BE 127-7.5-40

Device Description : BE 127-7.5-40 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port, (1 BE 127-7.5-40 Wye Connector with (2) 22mm OD ports, (1) 15mm ID/22mm OD port, (1) 7.5mm ID temperature probe port, and (1) barbed pressure port. Fits components of adult ventilator circuits. Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

BE 130 One-Way Valve - M996BE1300 Catalog Number :

Device Description : The reusable BE 130 One-Way Valve is designed for use in any breathing circuit o The reusable BE 130 One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

BE 130-22B One-way Valve - M996BE13022B0 Catalog Number :

Device Description : The reusable BE 130-22B One-Way Valve is designed for use in any breathing circu The reusable BE 130-22B One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.

Device Class :

Duns Number: 053146767

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

BE 130-23BB One-Way Valve - M996BE13023BB0 Catalog Number :

Device Description : The reusable BE 130-23BB One-Way Valve is designed for use in any breathing circ The reusable BE 130-23BB One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.

Device Class :

Duns Number: 053146767

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

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