BEUDAMED
    FDA Registration Active 🇺🇸 United States

    INSTRUMENTATION INDUSTRIES, INCORPORATED

    Reg #: 2518436 · FEI: 2518436 · Expires 2026
    View on FDA
    Products
    24
    Proprietary Names
    194
    Establishment Types
    4
    Classifications
    24

    Registration Details

    Registration Name
    INSTRUMENTATION INDUSTRIES, INCORPORATED
    Registration Number
    2518436
    FEI Number
    2518436
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2990 INDUSTRIAL BLVD
    City
    BETHEL PARK
    State
    PA
    ZIP
    15102
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091111
    PMA Number
    P800068

    Owner / Operator

    Firm Name
    INSTRUMENTATION INDUSTRIES, INCORPORATED
    Operator Number
    2518436
    Address
    2990 INDUSTRIAL BLVD.
    City
    Bethel Park
    State
    PA
    Postal Code
    15102
    Country
    US
    Correspondent
    EDWARD C HOREY, JR.

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF
    Valve, Non-Rebreathing CBP
    Ventilator, Continuous, Facility Use CBK
    Tube, Tracheostomy (W/Wo Connector) BTO
    Tape, Measuring, Rulers And Calipers FTY
    Meter, Airway Pressure (Inspiratory Force) BXR
    Cuff, Tracheal Tube, Inflatable BSK
    Tubing, Pressure And Accessories BYX
    Bag, Reservoir BTC
    Clip, Nose BXJ
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Drain, Tee (Water Trap) BYH
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Changer, Tube, Endotracheal LNZ
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Airway, Oropharyngeal, Anesthesiology CAE
    Support, Breathing Tube JAY
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Laryngoscope, Rigid CCW
    Connector, Airway (Extension) BZA
    Mouthpiece, Breathing BYP
    Mask, Oxygen BYG

    Proprietary Names

    RTC 24-V MDI Adapter RTC 24-V Kit MDI Adapter Kit RTC 21-A RTC 21-D Metered Dose Inhalers BE 30-115-BL BE 30-115-B NS 30-115-5 NS 30-115-UL NS 30-115-U NS 30-115-5L SG 066-2N Single-Use Breathing Bag SG 066 Oxygen Enrichment Kit ACU 1060.2 ACU 1060.1 NS Series NIF Meters NIF Meter Adapters and accessories BE 409 Pilot Tube Repair Kit CB 23-1 BE 105-40 SH 7-2 BE 167 MS 101-40 SC 603-A KC 5 BE 169 KC 145-2230D NP 130-22 BE 168 BE 145-2230P SH 74 Series Swivel Barbed Tubing Adapters CB 23 ADP 150 KC 145-1522D BE 145-2P KC 6PA SH 75 Series Swivel Barbed Tubing Adapters BE 145-1522P BE 105-101-40 BE 139 SR 75 Series KC 003N BE 150-5G KC 003N-2P BE 150-5LF KC 002N KC 002N-2P SG 066-2N-2P KC 00.5N-2P KC 00.5N EM 001-N SG 066-2N NOSE CLIP RTC 24-VP BE 3000-FA Instant Flow Valve BE 3000-RA Instant Flow Valve BE 3000-PA Instant Flow Valve BE 3000-FS Instant Flow Valve BE 3000-PS Instant Flow Valve BE 3000-WM Wall Mount for Instant Flow Valve BE 3000-RS Instant Flow Valve Gauge Clamps and accessories NS Series Airway Pressure Monitors NS Series Cuff Pressure Monitors WT 125 Water Trap WT 250 Water Trap HG 100 Humidifier Guard KC XXX-5P Tubing KC XXX-19R Tubing KC XXX-5 Tubing KC XXX-BC Tubing KC XXX-P22 Tubing KC XXX-GG Tubing NP 105-1 Safety Strap KC 10 Tubing Separator KC XXX-5N Tubing BE 102 Tubing Clamp KC XXX-B Tubing KC XXX-N Tubing KC XXX Tubing KC XXX-6 Tubing KC XXX-P Tubing KC XXX-3 Tubing RB 001 BE 117 JEM 350 Endotracheal Tube Changer JEM 330 Endotracheal Tube Changer JEM 355 Endotracheal Tube Changer JEM 365 Endotracheal Tube Changer JEM 325 Endotracheal Tube Changer JEM 360 Endotracheal Tube Changer JEM 401 Set of 9 Endotracheal Tube Changers JEM 400 Endotracheal Tube Changer JEM 340 Endotracheal Tube Changer JEM 370 Endotracheal Tube Changer RTC 22-A RTC 23-A RTC 17-1 RTC 23-D RTC 22-D RTC 26-C BE 183-SU-12 BE 183-2 BE 183-SU BE 183-6 BE 183-SUR-12 BE 183-G BE 183-R BE 183-SUR BE 127 KC 212-D SG 102 KC 18901-L SG 101-D AM 100P BE 127-7.5 BE 195-1522A SG 101 PF 1510 BE 105-2X22 BE 193 PF 1515 BE 191 PF 001 BE 117-W BE 101-00-3443 BE 190 BE 125 KM 030 BE 101-00-1426 BE 127-7.5-40 BE 120-AKW BE 125-1TD KC 211-D BE 125-1T KC 18901-P KC 213-D NB 105-6 BE 192 KC 18901-K SG 1010 SG 218 BE 125-1 KC 18901-O BE 105-2X22D SG 193-M BE 105-2222 BE 127-40 PF 1010 SH 77-6 SH 77-3 SH 77-2 SH 77-1 SH 77-S (Set of 7 sizes) SH 77-5 SH 77-7 SH 77-4 NS 120P-TRS Pressure Gauge BE 122-30 Flexible Support Arm BE 122-2TB RB 002 BE 114-2 BE 114-1 BE 114-5 BE 114-5TB BE 122-24 Flexible Support Arm BE 122-2TSB BE 30-142 Magnetic PEEP valve BE 142 Magnetic PEEP valve SM-MH and SM-PH Laryngoscope Handles AM MAC Macintosh Laryngoscope Blades AM MIL Miller Laryngoscope Blades CI-55 Anesthesia Holster KC 2119 DS 7-45 BE 16-2 BE 106 BE 105-7 KC 105 KC 2124 KC 1010 BE 105-8 BE 139-105 KC 2126 KC 1515 SH 7-45 BE 120-22D mouthpiece BE 4500 BB 4500-20D BE 4500-18D BE 130-22B BE 130 BE 131 BE 130-23BB

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer)