Accutron Inc

FDA Filings

This page includes the latest FDA filings for Accutron Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2020813
FEI Number2020813
NameACCUTRON, INC.
Owner & OperatorCrosstex International, Inc.
Contact Address10 Ranick Rd. --
Hauppauge NY 11788 US
Official Correspondent
  • Pablo Martinez
  • x-631-2571046-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1733 WEST PARKSIDE LN.
PHOENIX, AZ 85027 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
ACCUTRON, INC.
WAGD Chemetron x 1/2" MNPT 349762023-11-28
ACCUTRON, INC.
FRU, Display Assy Digi-Flo Zone Valve 28651-FRU2023-10-13
ACCUTRON, INC.
FRU, 4 Cylinder Remote Vacuum Kit 28326-FRU2023-10-13
ACCUTRON, INC.
FRU, Accuvalve Assembly 26786-FRU2023-10-13
ACCUTRON, INC.
Nitrogen Add On Kit 480222023-10-13
ACCUTRON, INC.
FRU, N2O Hose, 2 Cyl. 27173-FRU2023-10-13
ACCUTRON, INC.
FRU, O2 Hose, 2 Cyl. 27172-FRU2023-10-13
ACCUTRON, INC.
FRU, Gauge Newport O2 23589-FRU2023-10-13
ACCUTRON, INC.
FRU, Valve, Pressure Relief, Digi-Flo 27427-FRU2023-10-13
ACCUTRON, INC.
FRU, Axess Vacuum Gauge 26699-FRU2023-10-13
ACCUTRON, INC.
Accutron Vacuum Male Connector 340812023-10-13
ACCUTRON, INC.
FRU, Vacuum Connector With Barbs 273242023-10-13
ACCUTRON, INC.
Axess 90 Deg Outspout Connector 28417-FRU2023-10-10
ACCUTRON, INC.
FRU, Axess To Accuvac Adaptor 28559-FRU2023-10-10
ACCUTRON, INC.
FRU, Axess Scavenging Control, In-Line 28530-FRU2023-10-10
ACCUTRON, INC.
Axess CapnographyAdapters 530552023-10-02
ACCUTRON, INC.
Digi-Flo N2O & O2 Brazed Risers 28389-FRU2023-10-02
ACCUTRON, INC.
Zone Valve Adapter Box, Digi-Flo, NC 49400-NC2023-10-02
ACCUTRON, INC.
Zone Valve Adapter Box, Digi-Flo 494002023-10-02
ACCUTRON, INC.
Zone Valve, Digi-Flo 495502023-10-02
ACCUTRON, INC.
Pre-Install Digi-Flo B & D Wall Mount 490522023-10-02
ACCUTRON, INC.
Pre-Install Digi-Flo A & C Desk Mount 490512023-10-02
ACCUTRON, INC.
Riser, FRU, N2O, Cylinder Room 277542023-10-02
ACCUTRON, INC.
Riser, FRU, O2, Cylinder Room 277522023-10-02
ACCUTRON, INC.
Portable O2 System - Manual Resuscitator 380062023-10-02
ACCUTRON, INC.
Surface Q/C Vacuum Outlet 340792023-10-02
ACCUTRON, INC.
Surface Schrader N2 Outlet 34078-S2023-10-02
ACCUTRON, INC.
Surface Imperial N2 Outlet 34078-I2023-10-02
ACCUTRON, INC.
Surface Q/C O2 Outlet 340772023-10-02
ACCUTRON, INC.
Surface Q/C Dual Outlet 340762023-10-02
ACCUTRON, INC.
Surface Q/C Triple Outlet 340602023-10-02
ACCUTRON, INC.
Recessed QC Outlet Vacuum 340112023-10-02
ACCUTRON, INC.
Flowmeter, Digital FlushMount, INT 27076-INT2023-09-29
ACCUTRON, INC.
White Axess In-Line Circuit 28625-FRU2023-09-29
ACCUTRON, INC.
White Axess, RFS Circuit 28624-FRU2023-09-29
ACCUTRON, INC.
Reducer 1/4 NPT To 1/8 NPT 27082-FRU2023-09-29
ACCUTRON, INC.
Accutron Manifold Adapter Kit 28401-FRU2023-09-29
ACCUTRON, INC.
Belmed Manifold Adapter Kit 28408-FRU2023-09-29
ACCUTRON, INC.
Porter Manifold Adapter Kit 28406-FRU2023-09-29
ACCUTRON, INC.
Digi-Flo Pkg C, w Sec. Desk Alarm -NP 49350-NP2023-09-29
ACCUTRON, INC.
Digi-Flo Pkg C, w Sec. Desk Alarm 493502023-09-29
ACCUTRON, INC.
2nd Alarm, Digi-Flo, Wall, w Security 49054-S2023-09-29
ACCUTRON, INC.
2nd Alarm Panel, Digi-Flo, Wall 490542023-09-29
ACCUTRON, INC.
Digi-Flo Pkg D, w Sec. Wall Alarm -NP 49450-NP2023-09-29
ACCUTRON, INC.
Digi-Flo Pkg. D, w Security Wall Alarm 494502023-09-29
ACCUTRON, INC.
E Yoke Regulator Deluxe 350182023-09-29
ACCUTRON, INC.
Yoke, 4 Cyl. Tank, FRU 26607-FRU2023-09-29
ACCUTRON, INC.
Flowmeter, CM 319702023-09-29
ACCUTRON, INC.
FRU, Gauge Newport Int O2 23799-FRU2023-09-25
ACCUTRON, INC.
FRU, Gauge Newport N2O 23590-FRU2023-09-25
ACCUTRON, INC.
Pressure Relief 22486-FRU2023-09-25
ACCUTRON, INC.
FRU, Taupe Bagtee 26679-FRU2023-09-25
ACCUTRON, INC.
FRU, White Bagtee 26798-FRU2023-09-25
ACCUTRON, INC.
90° Mixed Gas Connector 263962023-09-25
ACCUTRON, INC.
DIGI-FLO PKG B, MANIFOLD W WALL ALARM, AUS 49250-AUS2023-09-22
ACCUTRON, INC.
ClearView Capnography Adapters 430552023-09-22
ACCUTRON, INC.
Digi-Flo Pkg. A, w Desk Alarm - NP 49150-NP2023-09-22
ACCUTRON, INC.
Digi-Flo Pkg A, Manifold Desk Alarm 491502023-09-22
ACCUTRON, INC.
Digi-Flo Pkg. B, w Wall Alarm - NP 49250-NP2023-09-22
ACCUTRON, INC.
Digi-Flo Pkg B, Manifold w Wall Alarm 492502023-09-22
ACCUTRON, INC.
Chair Conversion Kit 36800-CCK2023-09-22
ACCUTRON, INC.
Oxygen Manifold System 490002023-09-22
ACCUTRON, INC.
Nitrogen Manifold System 2 Tank 480002023-09-22
ACCUTRON, INC.
Zone Valve, Standard Manifold 395502023-09-22
ACCUTRON, INC.
Pre-Installation for B & D, Desk Alarm 380512023-09-22
ACCUTRON, INC.
Accutron Portable Oxygen System 380102023-09-22
ACCUTRON, INC.
Recessed Q/C O2 Outlet 340092023-09-22
ACCUTRON, INC.
Recessed Q/C Dual Outlet 340052023-09-22
ACCUTRON, INC.
Recessed Q/C Triple Outlet 340042023-09-22
ACCUTRON, INC.
FRU, Primary Check Valve O2 239132023-09-22
ACCUTRON, INC.
Digital Ultra Package F, UK 56500-UK2023-09-21
ACCUTRON, INC.
Digital Ultra Package C, International 56200-INT2023-09-21
ACCUTRON, INC.
Digital Ultra Flushmount Package G, INT 56600-INT2023-09-21
ACCUTRON, INC.
Digital Ultra Package C ADJS 56200-ADJS2023-09-21
ACCUTRON, INC.
Ultra DC Package C ADJS 46200-ADJS2023-09-21
ACCUTRON, INC.
Ultra PC % Package C ADJS 36200-ADJS2023-09-21
ACCUTRON, INC.
FRU, Pressure Transducer, 0-100 PSI, NPT 27872-FRU2023-09-21
ACCUTRON, INC.
FRU, Pressure Transducer, 0-100 PSI 27758-FRU2023-09-21
ACCUTRON, INC.
56800 Chair Conversion Kit 56800-CCK2023-09-21
ACCUTRON, INC.
Transducer, Guardian II Replacement Kit 25786-FRU2023-09-21
ACCUTRON, INC.
Ultra PC % Pkg B, International 36100-INT2023-09-21
ACCUTRON, INC.
Manifold With Desk Alarm, D (2+1), NP 38005-NP2023-09-21
ACCUTRON, INC.
Manifold With Wall Alarm, C (2+1), NP 38004-NP2023-09-21
ACCUTRON, INC.
Manifold With Desk Alarm, B (2+2), NP 38003-NP2023-09-21
ACCUTRON, INC.
Manifold With Wall Alarm, A (2+2), NP 38002-NP2023-09-21
ACCUTRON, INC.
4 Cylinder Stand, Analog 285002023-05-11
ACCUTRON, INC.
4 Cylinder Stand, Analog 283732023-05-11
ACCUTRON, INC.
4 Cylinder Stand, Digital 283742023-05-11
ACCUTRON, INC.
4 Cylinder Stand, Digital, SS 28374-SS2023-05-11
ACCUTRON, INC.
Main Module, Digital Flushmount 271922023-05-11
ACCUTRON, INC.
Main Module, Digital Flushmount, Brewer 27192-BWR2023-05-11
ACCUTRON, INC.
Adjustable Talll Mobile Stand 32005-AT2023-04-27
ACCUTRON, INC.
Ultra PC % Flowmeter, EU Model-50 % N2O 31975-EU502023-04-27
ACCUTRON, INC.
Ultra PC % Flowmeter, PEU Model 31975-PEU2023-04-27
ACCUTRON, INC.
Ultra PC % Flowmeter, EU Model 31975-EU2023-04-27
ACCUTRON, INC.
Flowmeter, Digital FlexMount, Wall Arm 26400-WA2023-04-27
ACCUTRON, INC.
Flowmeter, Digital Flexmount, 4 Cylinder 26400-4C2023-04-27
ACCUTRON, INC.
Flowmeter, Dig. FlexMount, Mobile Stand 26400-MS2023-04-27
ACCUTRON, INC.
Flowmeter, CM, Biewer 27514-BWR2023-04-27
ACCUTRON, INC.
International Newport Flowmeter System 50000-INT2023-04-27
ACCUTRON, INC. [Crosstex International, Inc.]
Gas-machine, anesthesia2016-08-02
ACCUTRON, INC. [Crosstex International, Inc.]
Ventilator, emergency, powered (resuscitator)2007-11-28
ACCUTRON, INC. [Crosstex International, Inc.]
Ventilator, emergency, manual (resuscitator)2007-11-28
ACCUTRON, INC. [Crosstex International, Inc.]
Gas-machine, anesthesia2007-11-28
ACCUTRON, INC. [Crosstex International, Inc.]
Apparatus, Gas-Scavenging2007-11-28
ACCUTRON, INC.
ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA2005-11-23
ACCUTRON, INC. [Crosstex International, Inc.]
ACCUTRON2005-01-13
ACCUTRON, INC. [Crosstex International, Inc.]
ACCUTRON2005-01-13
ACCUTRON, INC. [Crosstex International, Inc.]
ACCUTRON2005-01-13
ACCUTRON, INC.
RFS VACUUM GAUGE SCAVENGING CIRCUIT2004-03-12
ACCUTRON, INC. [Crosstex International, Inc.]
YOKE ASSEMBLY, MEDICAL GAS2003-10-07
ACCUTRON, INC. [Crosstex International, Inc.]
TRANSDUCER, GAS PRESSURE2003-10-07
ACCUTRON, INC. [Crosstex International, Inc.]
MASK, SCAVENGING View2001-06-23
ACCUTRON, INC.
GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 340761999-10-27
ACCUTRON, INC.
UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)1997-03-28
ACCUTRON, INC.
PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING SYSTEM(260-U AND 261-U)1997-03-28
ACCUTRON, INC. [Crosstex International, Inc.]
REGULATOR, PRESSURE, GAS CYLINDER1992-06-18
ACCUTRON, INC. [Crosstex International, Inc.]
TUBING, PRESSURE AND ACCESSORIES1992-06-18
ACCUTRON, INC. [Crosstex International, Inc.]
GAUGE, GAS PRESSURE, CYLINDER/PIPELINE1992-06-18
ACCUTRON, INC. [Crosstex International, Inc.]
BAG, RESERVOIR1992-06-18

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202007141392Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyBARE PRINTED CIRCUIT BOARD220 CTN
202007023406Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyBARE PRINTED CIRCUIT BOARD220 CTN
201908243977Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyX-RAY 90KV MACHINE AX8200/ NITROGEN GENERATOR E THIS SHIPMENT CONATINS NO SOLID WOOD PACKIN G MATERIALS.32 PKG
201907305198Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyBARE PRINTED CIRCUIT BOARD THIS SHIPMENT CON TAINS NO SOLID WOOD PACKING MATERIALS169 CTN
2019031614877Hong Kong,Hong Kong -> New York/Newark Area, Newark, New JerseyLABEL15 CTN
2019022512864Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyBARE PRINTED CIRCUIT BOARD91 CTN
2019011615531Yantian,China (Mainland) -> New York/Newark Area, Newark, New JerseyBARE PRINTED CIRCUIT BOARD.66 CTN
2018101866197Yantian,China (Mainland) -> Long Beach, CaliforniaBARE PRINTED CIRCUIT BOARD45 CTN

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