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

Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (2) Circuit, Breathing (W Connector, Adaptor, Y Piece) (CAI) (1) Meter, Airway Pressure (Inspiratory Force) (BXR) (1) Set, Tubing And Support, Ventilator (W Harness) (BZO) (1) Tape, Measuring, Rulers And Calipers (FTY) (1) Tubing, Pressure And Accessories (BYX) (1) Valve, Non-Rebreathing (CBP) (1) Analyzer, Gas, Oxygen, Gaseous-Phase (CCL) (1) Ventilator, Emergency, Manual (Resuscitator) (BTM) (1)

Premarket Exempt

Yes No

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MT100 Oxygen Sensor Activation System - M996MT1000 Catalog Number : MT 100

Device Description : The MT 100 Oxygen Sensor Activation System is designed for use with the Maxtec H The MT 100 Oxygen Sensor Activation System is designed for use with the Maxtec Handi Oxygen Analyzer. By utilizing a check valve in the Tee Adapter, an airtight seal is maintained in-line, unless actuated by the stem of the activator. This system therefore provides the capability of rapid monitoring of the patient breathing environment without the inconvenience of breaking the ventilation circuit.

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : CCL

Prescription Use : Yes

Device Count : 1

NB 105-6 Reducing Adapter - M996NB10560 Catalog Number : NB 105-6

Device Description : Reducing Adapter for use in breathing/ventilator circuit. - 22mm I.D. x 15mm I.D Reducing Adapter for use in breathing/ventilator circuit. - 22mm I.D. x 15mm I.D/22mm O.D. Molded of polycarbonate. Reusable.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : CAI

Prescription Use : No

Device Count : 1

NL 100 Breast Marker - M996NL1000 Catalog Number : NL 100

Device Description : NL 100 Breast Marker is used to assist in nipple placement during breast reconst NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm.

Device Class : 1

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : FTY

Prescription Use : No

Device Count : 1

NP 1000-2D O2 Instant Flow Valve Bag Hanger - M996NP10002D0 Catalog Number : NP 1000-2D

Device Description : NP 1000-2D Bag Hanger mates with arm of O2 Instant Flow Valve to support a resus NP 1000-2D Bag Hanger mates with arm of O2 Instant Flow Valve to support a resuscitation bag. This is an accessory to the BE 3000 Series Oxygen Instant Flow Valves. Single Patient Use

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : BTM

Prescription Use : Yes

Device Count : 1

NP 105-1 Safety Strap - M996NP10510 Catalog Number : NP 105-1

Device Description : Ventilator Tubing Accessory - Safety Strap helps to prevent disconnects by secur Ventilator Tubing Accessory - Safety Strap helps to prevent disconnects by securing ventilator circuit components.

Device Class :

Duns Number: 053146767

Premarket Exempt : Yes

Product Code : BZO

Prescription Use : No

Device Count : 1

NP 130-22 Adapter - M996NP130220 Catalog Number : NP 130-22

Device Description : The NP 130-22 Pressure Adapter: Dimensions - Barbed port fits 1/4" I.D. tubing, The NP 130-22 Pressure Adapter: Dimensions - Barbed port fits 1/4" I.D. tubing, x 15mm I.D./22mm O.D. x 22mm I.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

NS 120P-TRS Airway Pressure Monitor - M996NS120PTRS0 Catalog Number : NS 120P-TRS

Device Description : The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a de The Instrumentation Industries, Inc. NS 120P-TRS Airway Pressure Monitor is a device used to monitor patient airway pressure during ventilation with a manual resuscitation device or bag/mask unit. This device is intended to be used by or on the order of a physician.

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

NS 120-TRR Negative Inspiratory Force (NIF) Meter - M996NS120TRR0 Catalog Number : NS 120-TRR

Device Description : The Instrumentation Industries, Inc. NS Series Negative Inspiratory Force (NIF) The Instrumentation Industries, Inc. NS Series Negative Inspiratory Force (NIF) Meters are devices used to measure and monitor patient inspiratory effort. During use the NIF Meter is attached to the patient airway at a point that provides optimal readings of patient respiratory effort. Federal law restricts these devices to sale by or on the order of a physician.

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : BXR

Prescription Use : Yes

Device Count : 1

NS 120-TRS Airway Pressure Monitor - M996NS120TRS0 Catalog Number : NS 120-TRS

Device Description : The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devi The Instrumentation Industries, Inc. NS Series Airway Pressure Monitors are devices used to monitor patient airway pressure during ventilation within a breathing circuit. The pressure gauge is placed in the patient circuit at a point that provides optimal airway pressure readings. These devices are intended to be used by or on the order of a physician.

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

NS 30-115-5 Exhalation Valve - M996NS3011550 Catalog Number :

Device Description : This reusable exhalation valve is designed for use with ventilators. The exhala This reusable exhalation valve is designed for use with ventilators. The exhalation valve prevents the inspired gases from escaping through the passage that will be made available to expired gases via an inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.

Device Class : 2

Duns Number: 053146767

Premarket Exempt : No

Product Code : CBP

Prescription Use : Yes

Device Count : 1

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