BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PENTAX of America, Inc.

    Reg #: 2518897 · FEI: 1000080301 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    516
    Establishment Types
    3
    Classifications
    36

    Registration Details

    Registration Name
    PENTAX of America, Inc.
    Registration Number
    2518897
    FEI Number
    1000080301
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3 Paragon Drive
    City
    MONTVALE
    State
    NJ
    ZIP
    07645
    Country
    US

    Regulatory Submissions

    510(k) Number
    K884836

    Owner / Operator

    Firm Name
    HOYA Corporation PENTAX Division
    Operator Number
    8030235
    Address
    3 Paragon Drive
    City
    Montvale
    State
    NJ
    Postal Code
    07645
    Country
    US
    Correspondent
    Paresh Patel

    Products

    Device Name Product Code
    Laryngostroboscope EQL
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
    Ventilator, Non-Continuous (Respirator) BZD
    Washer, Cleaner, Automated, Endoscope NVE
    Camera, Television, Endoscopic, With Audio FWG
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    System, Imaging, Gastrointestinal, Wireless, Capsule NEZ
    Endoscopic Irrigation/Suction System OCX
    Accessories, Cleaning, For Endoscope FEB
    Camera, Surgical And Accessories KQM
    Endoscopic Leak Tester PCV
    Bedpan FOB
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Unit, Cryosurgical, Accessories GEH
    Cart, Emergency, Cardiopulmonary (Excluding Equipment) BZN
    Cleaner, Ultrasonic, Medical Instrument FLG
    Electroglottograph KLX
    Laparoscope, General & Plastic Surgery GCJ
    Light Source, Fiberoptic, Routine FCW
    Medical Device Data System OUG
    Monitor, Esophageal Motility, Anorectal Motility, And Tube KLA
    Device, Digital Image Storage, Radiological LMB
    Pump, Air, Non-Manual, For Endoscope FEQ
    Biopsy Needle FCG
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Camera, Television, Endoscopic, Without Audio FWF
    Bulb, Inflation, For Endoscope FCY
    Unit, Drying JRJ
    Accessories, Germicide, Cleaning, For Endoscopes NZA
    Transformer, Endoscope GCW
    System, Digital Image Communications, Radiological LMD
    Endoscope Channel Accessory ODC
    Sterilant, Medical Devices MED

    Proprietary Names

    VIDEO LARYNGOSTROBOSCOPE (VNL-1590STi) VIDEO LARYNGOSTROBOSCOPE (VLS-1590STI) VIDEO LARYNGOSTROBOSCOPE (VLS-1070STK) RIGID ENDOSCOPE, STERRAD (9109) VIDEO LARYNGOSTROBOSCOPE (VLS-1190STK) LARYNGEAL STROBE (9500) Footswitch for 9500(9500FS) Laryngeal Microphone for 9500(9500LX) Lapel Microphone for 9500(9500MC) VIDEO LARYNGOSTROBOSCOPE (VNL-1190STK) VIDEO LARYNGOSTROBOSCOPE (VNL-1070STK) FOOTSWITCH CABLE, FOR CGI-4000 (90048) ADAPTER, SCOPE CHANNEL FOR ENDO IRRIGATOR (84110) FOOTSWITCH, PNEUMATIC WATERPROOF (90047) ELECTRODE, BIPOLAR PATIENT PAD, BOX OF 25 (82171) BOTTLE, IRRIGATION W/MOUNTING SUPPORT BRACKET 500 ML (86337) CARTRIDGE W/SILICONE TUBING FOR ENDO IRRIGATOR PUMP (90046) RECEPTICLE, FOOT SWITCH CGI-4000 (84153) FOOTSWITCH W/INTEGRAL PNEUMATIC TUBING (90051) BOTTLE, IRRIGATION W/MOUNTING SUPPORT BRACKET 1000 ML (86345) TUBE, CONNECTING ENDO IRRIGATOR, BOX OF 12 (90050) RUBBER CGI-4000 FOOTSWITCH (90107) WATERBOTTLE HOLDER (EGA-7010) YOKE ADAPTER, EGA-501P (EGA-7012) CO2 INSUFFLATOR (EGA-501P) POWER CORD, EGA-500P/EGA-501P (EGA-7014) HIGH PRESSURE HOSE 3FT, EGA-501P (EGA-7011) CO2 INSUFLATOR (EGA-501) FILTER OVERFLOW PROTEC/BACT/W CONNEC 670 (67061) VARIO 18 (AC) SUCTION PUMP (67059) DISPOSABLE 2500CC BAG FOR PUMP 67059 (67078) SILICONE TUBING JAR TO PUMP MEDELA (67068) DISPOSABLE TUBING PATIENT TO PUMP MEDELA (67069) DISPOSABLE 1500CC BAG FOR PUMP 67059 (67077) F. WATER JET ADAPTER (86550) FORWARD WATER JET ADAPTER TUBE (86547) SUCTION CHANNEL ADAPTER TUBE (86549) A / W CHANNEL ADAPTER TUBE (86551) A / W / S VALVE CYLINDER CAP (86552) CHANNEL INLET ADAPTER TUBE (86548) PORTABLE RECORDABLE ENDSCOPY SYSTEM (7195B) HITACHI NOBLUS ULTRASOUND PROCESSOR W/SONOELASTOGRAPHY (NOBLUS) HITACHI NOBLUS ULTRASOUND PROCESSOR W/O SONOELASTOGRAPHY (NOBLUS-B) NOBLUS DEMO CRATE (NOBLUS CRATE) CapsoCam Plus Capsule Endoscope System (CAPSO2795) CAPSO VIEW SOFTWARE (CAPSO2758) 2.5 LITER CANISTER (67081) IRRIGATOR (PWI-V10C) CHANNEL SEPARTOR, PNTX (910601) CHANNEL PLUG (112401) CHANNEL CONNECTOR TUBE (907501) ADAPTER, WTRJT-IRR TUBE (945701) CONNTUBE (102401) CONNECTOR TUBE, WATER (845201) ADAPTER, WTRJT CONN TUBE (101701) CONNECTOR TUBE, BROWN (842103) CHANNEL CONNECTION TUBE (841001) ADAPTER,WATER/AIR (945202) CHANNEL CONN. TUBE, ORG (841701) CHANNEL CONN. TUBE, WHITE (841401) CHANNEL CONNECTOR TUBE (848102) ADAPTER, OE-C12 (102301) CHANNEL SEPARATOR PNTX (905601) CHANNEL SEPARATOR, PNTX (913501) ZWIRE G2 RADIANCE ULTRA 27 PAIR (NDS90Z0156) NDS 21" ENDOVUE DISPLAY (NDS90K0019) FILM PACK 50 PRINTS RIBBON 21/20MD 4PC (UPC-21L) FILMPACK UPC-21L 4PACKS X 50, 4RIBBONS (74187) POWER SUPPLY - NDS 32" SPLIT SCREEN MON. (M34021) TALL MONITOR POLE STAND (FLP-0001-70-VHRS) 22" DELL LCD MONITOR (72066) 42" RADIANCE G2 LED WITH SINGLE FIBER (NDS90R0070) NDS 24" ENDOVUE LED MONITOR (NDS24ENDO) NDS 19IN RADIANCE HD MONITOR MED GRADE (72064) PRINTER, COLOR (9264C) ZWIRE G2 RADIANCE ULTRA 27 SINGLE (NDS90Z0157) NDS CONDUCTOR VIDEO SWITCHING PACKAGE (KBMNDS-CONDOR) MONITOR 27" DELL PC (72067) 27" RADIANCE ULTRA MONITOR (NDS90X0660) XEROX NETWORK LASER PRINTER (74258) NDS 32" LED DISPLAY, W/O FIBER (NDS90X0619) FILM PACK 100 PRINTS RIBBON 55MD 2PC (UPC-55) NDS 24" LED MONITOR (NDS24LED) NDS 21” ENDOVUE MONITOR (NDS90K0061) HEAVY DUTY MONITOR POLE STAND (PE-0001-60) NATIONAL DISPLAY 26" RADIANCE HD LED MON (NDS26LED) FILM PACK B&W 240 PRINTS 897MD 10PC (UPP-110HG) VESA MOUNTING ADAPTOR (FLP-0002-17C) 24" LCD MONITOR HD (MONITOR ST) RADIANCE 55" G2 LED, W/SINGLE FIBER (NDS90R0069) RADIANCE 24" G2 W/SINGLE FIBER (NDS90R0064) NDS CONDUCTOR G2 BASE UNIT (NDS-CONDOR-BASE) STANDARD MONITOR POLE STAND (FLP-0001-93) UP-X898MD B&W VIDEO PRINTER (UP-X898MD) SONY UP-25MD COLOR VIDEO PRINTER (UP-25MD) FILM PACK 200 PRINTS RIBBON 51MDU/D50 (UPC-510) PRINTER, COLOR HP (7264C) PAPER AND RIBBON KIT (1111-1605) DEMO CASE FOR SCOPE, PROCESSOR & MONITOR (001-007V) ZEROWIRE G2 ACCESSORY KIT SINGLE FOR 32" (NDS90Z0179) CONDUCTOR (CONDUCT OR) POWER SUPPLY - NDS 23" AND 32" MONITOR (34019) SONY A6 COLOR VIDEO PRINTER 400DPI (UP-21MD) NDS RADIANCE ULTRA 32" ANALOG MONITOR (NDS90R0107) ZEROWIRE G2 PAIR RX & TX (NDS90T2070) POWER SUPPLY - NDS 26" LED MONITOR (34015) DEMO CASE FOR SCOPE, PROCESSOR & MONITOR (001-007S) DEMO CASE FOR SCOPE, PROCESSOR & MONITOR (001-007P) VERSA MONITOR (PM-V10c19) DEMO CASE FOR POLE STAND (001-007S-P) NDS 24" ENDOVUE MONITOR (NDS90X0711) DEMO CASE FOR POLE STAND (001-007S-N) NDS 24" ENDOVUE MONITOR (NDS90X0699) ZEROWIRE G2 ACCESSORY KIT PAIR FOR 32" (NDS90Z0178) PRINTER HP 6230 (1111-2098) 32" HD MEDICAL MONITOR (FSNL3202D) 55" 4K MEDICAL MONITOR (FSNC5501DV) NDS 24" ENDOVUE MONITOR (NDS90X0669) NDA 91in Radiance HD Monitor Med Grade(NDA90R0056) 26" HD MEDICAL MONITOR (FSNP2604D) PRINTER HP 6230 (E3E03A#B1H) ULTRASOUND SYSTEM W/SONOELASTOGRAPHY DEMO (HV-PREIRUS-D) HITACHI 5.1 PREIRUS UPGRADE SOFTWARE (HITACHI5.1UPGRD) ADVANCED ULTRASOUND SYSTEM W/SONOELASTOGRAPHY USED (HV-PREIRUS-U) HV-PREIRUS DEMO ESCORT CASE (HV-PREIRUS CRATE) HITACHI SONOELASTOGRAPHY SOFTWARE (M70228) HV-PREIRUS SYSTEM W/O SONOELASTOGRAPHY (HV-PREIRUS-B) ADVANCED ULTRASOUND SYSTEM W/SONOELASTOGRAPHY (HV-PREIRUS) Automatic Leakage Tester (PLT-V10c) CAPSULE RETRIEVAL PAN (1219-6) RETRIEVAL BAG (1219-2) RETRIEVAL WAND (1219-4) 360CC CUP (1219-5) RETRIEVAL VIAL (1219-3) SINUSCOPE 2.7MM, 30 (8851) ADAPTABLE TUBE (8860) SINUSCOPE 2.7MM, 30 WIDE ANGLE (8851-WA) SINUSCOPE 4MM, 0 DEG 175MM (8853) CONNECTOR TO LIGHT SOURCE (8876) SINUSCOPE 4MM 45 DEGREE (8855-WA) CONNECTOR TO SCOPE (8872) SINUSCOPE 4MM, 0 WIDE ANGLE (8853-WA) SINUSCOPE 2.7MM, 70 (8852) SINUSCOPE, 4MM 30 DEG 175MM (8854) SINUSCOPE 4MM, 30 WIDE ANGLE (8854-WA) CONNECTOR TO LIGHT SOURCE (8874) SINUSCOPE, 2.7MM 0 DEG, 175MM (8850) HANDLE FOR INSERT (8862) CONNECTOR TO SCOPE (8871) CONNECTOR/LIGHT SOURCE OLYMPUS (8875) CONNECTOR TO LIGHT SOURCE (8877) STERILIZATION BASKET (8845) LIGHT CABLE3.5 X 2300 (8870) SUCTION/IRRIGATION HANDLE (8857) OTOSCOPE 3MM, 69MM LONG (8868) SINUSCOPE 2.7MM, 0 WIDE ANGLE (8850-WA) SINUSCOPE, 4MM, 45 DEG, 175MM (8855) OTOSCOPE SHEATH (8869) ADAPTABLE TUBE (8861) SINUSCOPE 4MM, 70 WIDE ANGLE (8856-WA) SINUSCOPE 2.7MM, 70 WIDE ANGLE (8852-WA) CONNECTOR/LIGHT SOURCE PENTAX (8879) SINUSCOPE, 4MM, 70 DEG, 175MM (8856) C2 CryoAblation Full 8 Catheter PORTABLE SWALLOWING CART (7273) DESKTOP STAND FOR NDS 19/23IN MONITOR (80236) DESKTOP STND/NDS RADIANCE 26" HD MONITOR (80246) HANDLE FOR 2"/5 CM POST (RS-0004-18) DRAWER, DEEP FOR PREC. CART (M80197) COMPACT CART W/ ARM SYS. FOR FLAT PANEL (80242) DEMO CASE FOR LARGE CARTS - 80247 (001-007C-N) SCOPE HOLDER SINGLE (80201) DOUBLE GAS BOTTLE HOLDER FOR 80247 (80253) PREC. COMPACT CART H37.5XW24XD (80225) PRECISION TRAVEL CART H37.5 X W43 X D24. (80182) PREC. STANDARD CART FLAT PNL MON. MOUNT H (80233) PREC. TRAVEL CART W/FLAT MONITOR ARM H50 (80231) FLAT PNL MON ARM SET-COMPACT CART 80225 (80230) DEMO CASE FOR SMALL CARTS - 80242 (001-007C) MONITOR ARM MOUNTING KIT (80228) DESKTOP STAND FOR NDS 32IN MONITOR (80238) PRECISION FLAT PANEL WALL MOUNT SYSTEM C (80217) STANDARD CART (80247) MOUNTING BRACKET FOR NDS 32IN MONITOR (80240) POLE STAND PREC.FLAT PANEL MONITOR (80232) TRAY 30.4 CM X 40.6 CM FOR 2"/5 CM POST (RS-0018-03) DUAL SCOPE HOLDER FOR 80247 (80254) MONITOR MOUNT FOR 80247 (80249) TALL CART HUI (80233-2) PATCH PANEL FOR 80247 (80259) WALL MOUNT FOR NDS 42IN MONITOR (80239) COMPACT CART HUI (80225-2) UTILITY BASKET (RS-0001-24) CART, STROBE HUI (9272) CART, STROBE HUI 230V (9272E) ECONOMY CART (80226) DUAL SCOPE HOLDER TYPE II FOR PREC. CART (M80200) SINGLE GAS BOTTLE HOLDER FOR 80247 (80251) ENDOSCOPIC HOLDER (7174-8301-KIT) ENDOSCOPIC TROLLEY (PT-V10C) Stor-Locx With Key Lock (RST-0007-86) Slide Out Scope Bin Shelf with Handle (END-0003-03) LED Task Light (END-0002-03) Cart Bin (WM-0001-23) Dual CO2 Gas Bottle Holder (M80194) Monitor Mount with 19" Riser (FLP-0008-78) Vertical CPU Channel Mount (WM-0007-428) Flip Down Keyboard Tray (END-0002-02) Gas Cylinder Mount (WM-0009-88) SLIM CART (820CP) SLIM CART (802CP) Single CO2 Gas Bottle Holder (M80193) Endoscopy Cart (PEN-003-06) 1600VA Isolation Transformer (M80201) BURR BASKET - SMALL MESH BASKET (BB1) BRANDMAX TRI CLEAN ULTRASONIC CLEANER (U-5LH) C2 CryoAblation Cartridge, Regular C2 CryoAbation Swipe Catheter C2 CryoAblation Cartridge, Large C2 CryoAblation Controller C2 CyroAblation Full Catheter C2 CryoBalloon Focal Catheter RIGID ENDOSCOPE 70 DEG. 10MM (9106) LENS ADAPTOR - 45MM (9117) 5197-804 ZOOM COUPLER, 19.5MM (9118) LENS ADAPTOR 20MM (9703) RIGID ENDOSCOPE 70 DEG. 6MM (9108) LENS ADAPTOR FOR RIGID-35MM (9116) 5197-801 ZOOM COUPLER, 17.5MM (9118B) PENTAX Medical Rigid Laryngostroboscope (9107) PENTAX Medical Rigid Laryngostroboscope (9104) 5 AIRFLOW HEAD-MASK COUPLERS (6613) HAND-HELD SEPARATOR KIT (6453) CONDENSER MICROPHONE (4302) SWITCH BOX ASSEMBLY A-B (7190-2500) CARRYING CASE FOR NASOMETER - 1111-1791 (6454) NASOMETER II (6450) LAPTOP COMPUTER (4307-1) MICROPHONE ACCESSORY KIT (4345) SONA-SPEECH II (3650) CARDBOARD TUBES 2 CASES OF 55 (6610) REAL-TIME PITCH (5121) I-CAPE V SOFTWARE MODULE (5168) SPEECH MASTER UPGRADE (5298) FLOWHEAD TUBES, SET OF 8 (7189-4200) PHONATORY AERODYNAMICS SYS FOR CSL USERS (6600-1) MICROPHONE FOR MULTISPEECH (3706) FOOT SWITCH ASSEMBLY EPK (7193-5500) 30 ADULT MED. DISPOSABLE MASKS (6635) VOICE RANGE PROFILE - VRP PROGRAM (4326) VOICE ANALYSIS PROGRAM (9223) PHONATORY AERODYNAMIC SYSTEM (6600) SCREENING TUBES, QTY 10 (6612) ADSV (5109) 30 ADULT SMALL DISPOSABLE MASK (6625) MOTOR SPEECH PROFILE (5141) SONA MATCH (5127) MICROPHONE, DYNAMIC (3709) MULTI DIMENSIONAL VOICE PROG (5105) AUDITORY FEEDBACK MODULE (3506) COMPUTERIZED SPEECH LAB (4500) 30 PEDIATRIC DISPOSABLE MASKS (6615) INTRAORAL TUBES, QTY 50 (6611) REAL TIME SPECTROGRAM (5129) COMPUTERIZED SPEECH LAB - JAPAN (4500-JP) MULTI SPEECH (3700) 30 ADULT LARGE DISPOSABLE MASK (6645) FLOWHEAD, EXTRA (6601) HEADSET CUSHIONS (6455) VISI-PITCH IV (3950B) PRESS. PORT TUBES 25QTY (6614) MICROPHONE PRE-AMP (3708) GAMES, SOFTWARE (5167B) COMPUTER, CORE I5 3.2GHZ, 4GB (4307) COMPUTERIZED SPEECH LAB (4500b) ADULT FACE MASK, EXTRA (6602) V4 PAS WIN10 UPGRADE (6600WU) PEDIATRIC MASK W/ADAPTOR (6606) V4 VISI-PITCH WIN10 UPGRADE (3950WU) VISI-PITCH IV - JAPAN (3950B-JP) NASOMETER II - JAPAN (6450-JP) STEINBERG PRE-AMP KIT (3714) NASOMETER HEADSET (6501) V4 NASOMETER WIN10 UPGRADE (6450WU) VISI-PITCH (3950c) TUBES, MOUTHPIECE, QTY 55 (7189-4000) V4 CSL WIN10 UPGRADE (4500WU) Nasometer II (6500) PAS DISPOSABLE ACCESSORIES KIT (6650) 6650: PAS disposables kit Mic Preamp Kit(3715) 6651: PAS 6600 microphone kit MIC and PREAMP for Multispeech(3706-1) CONNECTOR CLEANING (2-8-431HAN) CONNECTOR CLEANING (2-8-536HAN) CONNECTOR CLEANING (2-8-537HAN) CONNECTOR CLEANING (2-8-330HAN) CONNECTOR CLEANING (2-8-612HAN) XENON BULB (2140-0028) WOLFE ADAPTER FOR PENTAX SCOPE (9122D) PENTAX ADAPTOR W/ FILTER (9122C) MIC, LAPEL ASSY REV D (7175-6000) LARYNGEAL STROBE (9400) ADAPTOR FOR OLYMPUS (9120) ENDOSCOPE ADAPTER (9125) ADAPTOR FOR STORZ (9121) PENTAX ADAPTOR (9122) PENTAX ADAPTOR W/O FILTER (9122B) ENDOSCOPE ADAPTER (9124) WOLF RIGID SCOPE ADAPTOR (9123) 150W HALOGEN LAMP (MU0P00000705) LARYNGEAL MICROPHONE (MU0P00000718) FOOT SWITCH MODULE (7192-9300) 32" RADIANCE MONITOR (NDS90X0702) Coldplay CryoBalloon Swipe Ablation Handle Coldplay Cryoballoon Full Ablation System Coldplay CryoBalloon Swipe Ablation Catheter Coldplay CryoBalloon Swipe Ablation System Coldplay CryoBalloon Ablation Cartridge Coldplay CryoBalloon Full Ablation Handle Coldplay CryoBalloon Full Ablation Catheter XENON LIGHTSOURCE (7150B) ENDOPRO IQ CAPTURE LICENSE (M70206-UP) ATEN VS162,2 PORT DVI VIDEO SPLITTERS (90138) ASSY: ECAP NTSC 6 CHANNEL (KBM68306) ENDOPRO IQ REVIEW LICENSE, 10-19 (M70217) NURSING NOTES (M70214-UP) PATHOLOGY SYSTEM INTERFACE (M70224-UP) VITALS MONITOR INTERFACE (M70223) HL7 INBOUND INTERFACE, ADT/SIU/ORM (M70220) ENDOPRO IQ REVIEW LICENSE, 10-19 (M70217-UP) DATA INTERFACE: OLYMPUS/FUJINON (68384) HL7 OUTBOUND INTERFACE UNC/PDF ADD-ON (M70222) HL7 OUTBOUND INTERFACE, ORU (M70221-UP) DIGITAL VIDEO CAPTURE MODULE (9200D) HL7 INBOUND INTERFACE, ADT/SIU/ORM (M70220-UP) VIDEO VIEWER FOR KAYPENTAX DIGITAL VIDEO (9221) ENDOPRO IQ REVIEW LICENSE, UNLIMITED (M70219-UP) ENDOPRO IQ HOSPITAL SITE LICENSE (M70207) IQ ADVANCED ANALYTICS, 3 TOKENS (M70230) ASSY: SERVER, RACK MOUNT FORM FACTOR (KBM68312) ENDOPRO IQ DOD SITE LICENSE, PER SITE (M70234) MICROSOFT SQL RUNTIME (M70227) MATROX VIO CAPTURE CARD (M30119) FILE SERVER DELUXE RACK MOUNTABLE (68394) ASSY: SERVER, TOWER FORM FACTOR (KBM68311) MPS VIDEO CAPTURE (M70212-UP) MEDICAL GRADE FOOTSWITCH (90139) DIGITAL CAPTURE (9372HD) COMPUTER DIGITAL VIDEO SYSTEM (7245D) NURSING NOTES (M70214) ENDOPRO IQ REVIEW LICENSE, 1-4 (M70216) FOOTSWITCH: MPS THREE PEDAL (68354) ENDOPRO IQ REVIEW LICENSE, 20-30 (M70218) DOC-U-SCRIBE REPORTING (M70213) ENDOPORTAL UPGRADE (9265) ENDOREMOTE (M70211) MIC PRE-AMP KIT, ROLLS MP-13 (7190-5300) FOOT SWITCH, USB-FS81-SP-USB (1111-1978) EXTRON 4 CHANNEL VGA VIDEO SWITCH (68404) COMPUTER ACCESSORIES (68403-ACC) ENDOSERVER WORKSTATION LICENSE (9282-3) VITALS MONITOR INTERFACE (M70223-UP) HD DVI IMAGE CAPTURE PC (KBM68403) ENDOPRO IQ REVIEW LICENSE, UNLIMITED (M70219) ENDOPRO IQ REVIEW LICENSE, 20-30 (M70218-UP) ENDOREMOTE (M70211-UP) ENDOPRO IQ, PER OR ROOM (M70210) DICOM COMPLIANCE MODULE FOR STROBOSCOPY (9251) ENDOPRO IQ HOSPITAL SITE LICENSE (M70207-UP) ENDOPRO IQ CAPTURE LICENSE (M70206) HL7 OUTBOUND INTERFACE, ORU (M70221) MS SQL STD - 8 CORE LICENSE (MSSQL-S8) STANDALONE IMAGE CAPTURE PC (KBM68407) HD - DIGITAL VIDEO CAPTURE (9310HD) DVD-RW DRIVE, EXTERNAL USB (1111-1977) IMAGE CAPTURE PC (KBM68406) COMPUTER ACCESSORIES (68391-ACC) CAPSOACCESS (CAPSO2668) FOOTSWITCH: MPS SINGLE PEDAL (90108) ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE (M70204) HD SDI IMAGE CAPTURE PC (KBM68404) ENDOPORTAL (9263) ENDOPRO IQ, PER MOBILE CART (M70209) ENDOPRO IQ REVIEW LICENSE, 5-9 (M70205-UP) PATHOLOGY SYSTEM INTERFACE (M70224) ENDOPORTAL WORKSTATION LICENSE (9252-1) ENDOPRO IQ AMBULATORY SITE LICENSE (M70208) HL7 INTERFACE OUTBOUND (9269) SCAN CONVERTER (7138) IQ ANALYTICS 5 USER LICENSE PACK (M70229) ENDOPRO IQ REVIEW LICENSE, 5-9 (M70205) IQ ADVANCED ANALYTICS, 5 TOKENS (M70235) MICROSOFT SQL ENTERPRISE EDITION (M70225) ENDOPRO IQ CITRIX/VIRTUALIZATION LICENSE (M70204-UP) ASSY: MPS DV/SD CAPTURE (KBM68303) ENDOPRO IQ AMBULATORY SITE LICENSE (M70208-UP) ENDOPRO IQ, PER MOBILE CART (M70209-UP) ENDOPRO IQ, PER OR ROOM (M70210-UP) Billing Module (M70243) UNIVERSAL POWER SUPPLY WITH BACKUP (68262) MPS VIDEO CAPTURE (M70212) ASSY: REVIEW/SCHEDULING PC (KBM68307) MATROX ORION HD CAPTURE CARD (M30126) DOC-U-SCRIBE REPORTING (M70213-UP) MICROSOFT SQL STANDARD EDITION (M70226) HL7 INTERFACE INBOUND (9267) HL7 OUTBOUND INTERFACE, UNC/PDF (M70222-UP) FIBER GRAPHICS EXTENSION RECEIVER (68395) DICOM INTERFACE FOR SWALLOWING (7251) ENDOPRO IQ REVIEW LICENSE, 1-4 (M70216-UP) Complete HL7 Interface Package Split (M70245-SPLIT) ENDOPRO CAPTURE WORKSTATION (KBM68346) endoPRO 2020 Pentax connect for Capulse (M70240) Scope Management (M70244) Complete HL7 Interface Package (M70245) Pathology Reports Interface (M70237) USB SWITCH INTERFACE (9173B) CapsoConnect (M70241) endoSHEET (M70248) Pathology Module (M70238) DICOM Module (M70242) Pathology Module Complete (M70239) Pathology Orders Interface (M70236) DIGITAL CAPTURE (9380) C2 CryoAblation Swipe Catheter C2 vCryoAblation Full Catheter CONNECTOR CLEANING (CLM-110-HU0145) CONNECTOR CLEANING (CLM-110-HU0080) CONNECTOR CLEANING (CLM-110-HU0137) CONNECTOR CLEANING (CLM-110-HU0138) ELECTROGLOTTOGRAPH - EGG, 230V (6103-230V) EGG ELECTRODE STRAPS - 3 SIZES (7175-6100) REAL TIME EGG PROCESSING (5138) ELECTROGLOTTOGRAPH - EGG, 120V (6103) MANOMETRY SENSORS (7123) LARYNGEAL MICROPHONE (7126) TONGUE ARRAYS (7179-0035) NASAL CANNULAS, CASE OF 50 PCS (7125) EMG TRANSDUCERS - TWO CHANNEL (7122) TONGUE ARRAYS (7179-0040) NASAL CANNULAS (7179-0030) TONGUE HARDWARE W/25 ARRAYS (7124) TONGUE ARRAYS (7183-4500) REMOVABLE HARD DRIVES FOR 7245C (7202B) MEDICAPTURE USB 300 (9139HD) MEDICAPTURE USB 200 (9139) Medicap MVR PRO (9139PROV) MVR PRO ONLY (MVR409) IRRIG TUBING, EGA-500P, 10/PKG (100130) WATERJET CONN, DISP, SINGLE, 10/PKG (1002420 PUMP HEAD FOR EGA-500P (EGA-7016) IRRIGATION PUMP (EGA-500P) MEDIVATORS FOOT PEDAL (47049-942) ENDOBRONCHIAL ULTRASOUND FLEX TBNA NEEDL (82448) ENDOBRONCHIAL TBNA NEEDLE 22GA 4L 5PC (82447) DISPOSABLE 2500CC LINER WITH SOLIDIFIER (67078) DISPOSABLE 1500CC LINER WITH SOLIDIFIER (67077) 1.5 LITER CANISTER (67080) PUMP HEAD FOR EGP-100P (EGP-014) ENDO-GATOR IRRIGATION PUMP (EGP-100P) MEDELA VARIO ADAPTER USE WITH 67077 (67079) CORD FOR EGP-100P (EGP-012) BIOPSY TUBING,SINGLE USE PKG 10 (100135P) WATER BOTTLE HOLDER (200270P) CARTRIDGE FOR EI 400C, REUSEABLE (100110P) IRRIGATION PUMP (EGA-500) FOOTSWITCH FOR EGP-100P (EGP-009) TUBING EGP-100P 24HOUR USE PKG 10 (200230) ENDO-GATOR IRRIGATION PUMP (EGP-100) CO2 TUBING EGA-501 10/PKG (100551) DISPOCAP CO2, 10/PKG (100150CO2) DISPOCAP AIR, 10/PKG (100160) Endoscopic CO2 Insufflator (PCI-V10c) EUS-Arietta 70 LIGHT SOURCE 50W LED, 2 PORT (7153-02) LED LIGHTSOURCE - ACMI - 1111-1917 (7154) LIGHT SOURCE 50W LED (7153) HD CAMERA - HD MOS (9215) EYEPIECE ADAPTOR W/CENTERING (84128) EYEPIECE ADAPTER FOR PTX OCULAR W/PSV4000 (84139) HD CAMERA - 3CCD (9214HD) CONNECTOR CLEANING (DSD-110-HU0028) CONNECTOR CLEANING (DSD-110-HU0144) CONNECTOR CLEANING (DSD-110-HU0109) MEDICAL LEAK TEST ADAPT (ZUTR10001PA) HANDHELD LEAK TESTER (ZUTR10002P) AUTO LEAK TESTER POWER SUPPLY (ZUTRT1079P5PND) AUTO LEAK TESTER - SUCTION CUP (ZUTR10003P) AUTOMATIC LEAK TESTER C (ZUTR10003TG) AUTO LEAK TESTER- WALL MOUNT BRKT (ZUTR10003WMP) HITACHI DUAL FOOTSWITCH (EZU-FS2) CONNECTOR CLEANING J&J (20375) CONNECTOR CLEANING J&J (20366) PlasmaTYPHOONdry FLOW UNIT 4 (EPSC004INT) FLOW UNIT 1 (EPSC001INT) ISOLATION TRANSFORMER 1200V 10A 4 OUTLETS (90075) ISOLATION TRANS 100/120/240V (9175) ISOLATION TRANS 120/230V (9174) 3G/HD-SDI/SDI OUTPUT MODULE (90T1008) DVI OUTPUT MODULE (90T1006) DVI INPUT MODULE (90T1005) DVI FOUR FIBER OUTPUT MODULE (90T1009) SCALEOR, DVI INPUT, W/OUT FIBER (SCALE OR) SCALEOR, DVI INPUT, W/FIBER (90T0010) 3G/HD-SDI/SDI INPUT MODULE (90T1007) FSN VIDEO SWITCHING PACKAGE (FSNIPS 1000A) Single Use 2 Piece Valve Set,90,i10,i10c (GAR037C) Single Use 3 Piece Valve Set,90,i10,i10c (GAR037P) Single Use Aux Water Conn,90,i10,i10c (GAR048) Single Use 4 Piece Valve Set,90,i10,i10c (GAR081P) Single Use Biopsy Valve,90,i10,i10c (GAR018P) ADAPTER FOR 70K WITH FWJ (QPC1724) ADAPTER FOR EB-70K (QPC1670) ADAPTER FOR 70K W/O FWJ (QPC1713)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device