BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Covidien

    Reg #: 9610849 · FEI: 3002807391 · Expires 2026
    View on FDA
    Products
    52
    Proprietary Names
    241
    Establishment Types
    3
    Classifications
    51

    Registration Details

    Registration Name
    Covidien
    Registration Number
    9610849
    FEI Number
    3002807391
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Boulevard Insurgentes 19030 Libramiento
    City
    TIJUANA, B.C. Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K862046

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    Products

    Device Name Product Code
    Catheter, Peritoneal, Long-Term Indwelling FJS
    Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase CCK
    Tape And Bandage, Adhesive KGX
    Oximeter DQA
    Pump, Infusion, Enteral LZH
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Device, Vascular, For Promoting Embolization KRD
    Accessories, Cleaning, For Endoscope FEB
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Stylet, Catheter DRB
    Staple, Removable (Skin) GDT
    Needle, Hypodermic, Single Lumen FMI
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Catheter, Hemodialysis, Triple Lumen, Non-Implanted NIE
    Catheter, Hemodialysis, Non-Implanted MPB
    Oximeter, Ear DPZ
    Tubes, Gastrointestinal (And Accessories) KNT
    Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) FCM
    Ventilator, Continuous, Facility Use CBK
    Ventilator, Non-Continuous (Respirator) BZD
    Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days FOZ
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Mask, Oxygen BYG
    Thoracentesis Tray PXI
    Injector And Syringe, Angiographic DXT
    System, Thermal Regulating DWJ
    Punch, Surgical LRY
    Catheter, Urological KOD
    Stopcock, I.V. Set FMG
    Transducer, Blood-Pressure, Extravascular DRS
    Dilator, Vessel, For Percutaneous Catheterization DRE
    Dialysis Administration Kit PEV
    LDQ
    Wire, Guide, Catheter DQX
    Spirometer, Diagnostic BZG
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Tourniquet Kit OJS
    Electrode, Electrosurgical JOS
    Kit, Repair, Catheter, Hemodialysis NFK
    Catheter, Hemodialysis, Implanted MSD
    Cable, Transducer And Electrode, Patient, (Including Connector) DSA
    Monitor, Breathing Frequency BZQ
    Catheter, Peritoneal Dialysis, Single Use FKO
    Catheter, Hemodialysis, Implanted, Coated NYU
    Accessories, Catheter KGZ
    Tube, Double Lumen For Intestinal Decompression And/Or Intubation FEG
    Gastrointestinal Tubes With Enteral Specific Connectors PIF
    Needle, Aspiration And Injection, Reusable GDM
    Illuminator, Fiberoptic, Surgical Field HBI
    Catheter, Retention, Barium Enema With Bag FGD
    Oximeter, Reprocessed NLF
    Catheter, Ventricular, General & Plastic Surgery GBS

    Proprietary Names

    Argyle Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Stencil Argyle Pediatric Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Kit Argyle Neonatal Peritoneal Dialysis Catheter Nellcor™ EASYCAP II Adult Colorimetric CO2 Detector, Nellcor™ PEDICAP Pediatric Colorimetric CO2 Detector Pediatric-Infant Adhesive Sensor Wrap Adult-Neonatal Adhesive Sensor Wrap Adult-Neonatal Foam Sensor Wrap Pediatric-Infant Foam Sensor Wrap Medtronic Oximeters Reusable Handswitching Pencil Valleylab™ Rocker Switch Pencil ERBE, Reuseable, E2100E Valleylab™ Rocker Switch Pencil Reusable, E2100 Micro Vascular Plug System (MVP) ANTI-FOG W/ & W/O Tube Gas/Pres Monit ET Conn/Adop TUNNELING STYLET SFS Stapler McKesson Skin Staplers 35 REGULAR Appose Skin Staplers Signet McKesson Skin Staplers 35 WIDE ConcordeMultifire Premium skin stapler Pedi-Cap Coated Electrodes MONOJECT LIFESHIELD Cannula Puritan-Bennett Nasal CPAP Mask Mahurkar™ Acute Single Lumen Catheter Straight Extension 8 Fr/Ch (2.7 mm) x 15 cm Mahurkar™ Acute Single Lumen Catheter Straight Extension 8 Fr/Ch (2.7 mm) x 19.5 cm Mahurkar™ Acute Catheter Accessory Y-Adapter Mahurkar™ Acute Single Lumen Catheter Kit Straight Extension 8 Fr/Ch (2.7 mm) x 15 cm Mahurkar™ Acute Single Lumen Catheter Kit Curved Extension 8 Fr/Ch (2.7 mm) x 15 cm Mahurkar™ Acute Single Lumen Catheter Kit Straight Extension8 Fr/Ch (2.7 mm) x 19.5 cm Force TriVerse™ Electrosurgical Device Holster 10' (3 m), FT3000 Force TriVerse™ Electrosurgical Device Holster 15' (4.6 m), FT300DB Oximax Pulse Oximetry System Nellcor N-200 Pulse Oximeter KANGAROO Enteral Feeding Pumps Sets Kangaroo Pump Set Kangaroo Gravity Feeding Bag Dover 100% Silicone Foley Catheter Model E2515 Electrosurgical Accesso Puritan Bennett 980 Series Ventilator System Breeze Sleepgear with Dreamseal Argyle Peritoneal Dialysis Accessory Oximax Softcare Sensors Capno-Flo Polyhesive Patient Return Electrode Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507 Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7508 Valleylab™ REM Polyhesive™ Adult Patient Return Electrode, E7507DB Valleylab™ Non-REM Polyhesive™ Patient Return Electrode, E7506 Dura-Y Sensor & Ear Clip Ritus Single Patient Use Nasal (CPAP) Cir Valleylab REM patient return electrode cord Polyhesive II Patient Return Electr REM patient return electrode cord Valleylab™ REM™ Patient Return Electrode Cord, Reusable, 15' (4.6 m), E0560 Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7509B Valleylab™ Cord Clamp ERBE™, Reusable 15/ (4.6 m), E0560E Valleylab™ REM Polyhesive™ Adult Cordless Patient Return Electrode, E7509 Turkel Safety Fluid Drainage System Angiomat Illumena Warmtouch Cardiac Blanket Salem Sump Silicone Dual Lumen Stomach Tube AGRYLE SALEM SUMP Nasogastric Tubes Punch Kangaroo 924 Safety Screw Spike Set DOVER Foley Catheter Tray Dover Pediatric Silicone Elastomer Coated Latex Foley Catheter Dover Silicone Elastomer Coated Latex Foley Catheter Dover Hydrogel Coated Urethral Catheter Nellcor™ OxySoft™ Neonatal-Adult SpO2 Sensor Microvascular Plug MAHURKAR Acute Dual Lumen High Flow Catheter Kits and Trays Tandem Assembled 3 & 4 Way Stopcocks Angiomat 6000 and accessories Argyle Presternal Peritoneal Dialysis Catheter Trays Argyle Presternal Peritoneal Dialysis Catheter Kit Argyle Presternal Peritoneal Dialysis Catheter Disp. Dome Force TriVerse Mahurkar Safety Insertion Tray DEVON Skin Marker - Sterile Labels Valleylab™ Solid Laparoscopic Electrode, Wire L-Hook Solid, 45 cm, E2773-45 Valleylab™ Laparoscopic Cylindrical Electrode, Hollow, 28 cm, E2786-28 Valleylab ™ Laparoscopic Handset, Four-Function, E2750 and E2750NSB Valleylab™ Solid Laparoscopic Electrode, Flat L-Hook Solid, 36 cm, E2774-36 Valleylab™ Laparoscopic Wire J-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2782R-28ASP Valleylab™ Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Holes, 28 cm, E2781R-28ASP Valleylab™ Laparoscopic Flat L-Hook Electrode, Hollow, 28 cm, E2784-28 Valleylab™ Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 36 cm, E2783R-36ASP Valleylab™ Laparoscopic Wire L-hook Electrode, Hollow, 28 cm, E2783-28 Valleylab™ Solid Laparoscopic Curved Spatula Electrode, Solid, 36 cm, E2771-36 Valleylab™ Laparoscopic Wire J-hook Electrode, 28 cm, E2782-28 Valleylab™ Laparoscopic Wire L-Hook Electrode, Retractable Aspiration Holes, 28 cm, E2783R-28ASP Valleylab™ Laparoscopic Curved Spatula Electrode, Hollow, 28 cm, E2781-28 Valleylab™ Laparoscopic Straight Spatula Electrode, Hollow, 28 cm, E2780-28 Valleylab™ Laparoscopic Flat L-Hook Electrode, Retractable, Aspiration Holes, 28 cm, E2784R-28ASP Valleylab™ Solid Laparoscopic Electrode, Wire J-Hook Solid, 36 cm, E2772-36 Valleylab™ Solid Laparoscopic Electrode, Wire L-Hook Solid, 36 cm, E2773-36 Valleylab™ Solid Laparoscopic Curved Spatula Electrode, Solid, 45 cm, E2771-45 Valleylab™ Solid Laparoscopic Straight Spatula Electrode, Solid, 36 cm, E2770-36 ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter Argyle Peritoneal Dialysis Accessories Argyle J/Straight Stainless Steel Guidewire Reflectance Sensor Renaissance 11 Spirometry System Humidifier-Cascade II Argyle Vascular Tourniquet Kit Argyle Vascular Tourniquet Valleylab™ REM Polyhesive™ Neonatal Patient Return Electrode, E7512 Valleylab Blade Electrode Valleylab¿ Ball Electrode Valleylab¿ Straight Extension Valleylab Needle Electrode Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm, E1005 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB Valleylab Ball Electrode, Reusable, 5.6 mm, E1002 Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm), E1551XNSB Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB Valleylab Straight Extension, 34.3 cm, E1504 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552 Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm), E1003 Valleylab Ball Electrode, Reusable, 3.2 mm, E1000 Valleylab Straight Extension, 13 cm, E1502 Valleylab Ball Electrode, 5 mm, E1550 Palindrome RT Repair Kit Optistar LE Optistar MR Sterile Extension Tubes, Ind. Pkg. Covidien Valleylab Straight Extension Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm),E1003 Valleylab Ball Electrode Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm),E1551XNSB Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm,E1005 Argyle Faller Tunneling Trocar Handifil Electrodes Valleylab™ Button Switch Pencil Needle Electrode, Holster, E2516HDA Valleylab™ Button Switch Pencil Holster, E2516H, E2516HGNSB, and E2516HNSB Valleylab™ Rocker Switch Pencil, E2515, E2515NSB, and E2515GNSB Valleylab™ Rocker Switch Pencil Holster, E2515H, E2515HDB, E2515HDBNSB, E2515HGNSB, and E2515HNSB Valleylab™ Rocker Switch Pencil Needle Electrode, Holster, E2515HDA and E2515HDANSB Valleylab™ Button Switch Pencil, E2516, E2516GNSB, and E2516NSB Valleylab™ REM Polyhesive™ Infant Patient Return Electrode, E7510-25DB Valleylab™ REM Polyhesive™ Infant Patient Return Electrode, E7510-25 High Pressure Flex ConnectingTubing 3 & 4 Way Plastic Stopcocks Nonsterile Covidien Nellcor Adult Respiratory Sensor Covidien Nellcor Respiration Rate Software, Version 1 MODIFIED USE OF PULL-APART INTRODUCER SET Warmtouch Blanket Palindrome Precision Chronic Catheter Kits and Sport Packs Palindrome Precision SI Chronic Catheter Kits and Sport Packs Palindrome Precision HSI Chronic Catheter Kits and Sport Packs Palindrome Precision H Chronic Catheter Kits and Sport Packs Palindrome Precision RT Chronic Catheter Kits PMR-2 Puritan Manual Resuscitator Argyle Penrose Tubing Oxisensor II N-395 Oximeter Salem Sump with EnFit INDGO Manual Resuscitator MAHURKAR Chronic Carbothane Catheter Kit, Trays, and Sport Packs Palindrome RT Chronic Catheter Kit Palindrome Chronic Catheter Kits and Sport Packs Puritan Bennett 840 Series Ventilator System Monoject Sternal-Iliac Aspiration Needle IRRIGATION SYSTEM VITAL VUE ILLUMINATION Breathsensor Dover & Oximax Sensors Reprocessed Nellcor Oxisensor II Laparoscopic Handswitch/Electrodes Resuscitator DMR Plus Disposable Manual Plas. Stck. w/extension tube/steril Acute and Chronic Catheter Repair Kit Closure Fast Individually Packaged 3 and 4 Way Plastic Sterile Stopcoc Edge™ Insulated Blade Electrode, E1455G WarmTouch Blanket Argyle Silicone Thoracic Catheter Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender Argyle Peritoneal Dialysis Catheter And Kits Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter Argyle Presternal Peritoneal Dialysis Catheter And Kits Micro-Needle Electrodes, E16XX Edge Needle Electrode, (6.5" (, 16.51 cm), E1452-6 Edge Insulated Blade Electrode, (4", (10.16 cm), E1455-4 and E1455-4NSB Edge Blade Electrode, (3” (, 7.62 cm), E1450G and E1450GNSB Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HGNSB Edge Insulated Blade Electrode, Safety Sleeve, (4" (, 10.16 cm), E1455B4 Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350H Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465NSB Edge Insulated Blade Electrode, (6.5", (16.51 cm), E1455-6 and E1455-6NSB Edge Insulated Blade Electrode, Safety Sleeve (2.75", (7 cm), E1455NSB Edge Insulated Blade Electrode, Safety Sleeve, (2.75", (7 cm), E1455BNSB Valleylab™ Insulated Micro-Needle Electrode, 9 cm, E1654B Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HGNSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HSNSB Valleylab™ Straight Micro-Needle Electrode, 2 cm, E1650 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HNSB Edge Coated Blade Extended Electrode, ( 4" , (10.16 cm), E1450-4 Edge Blade Electrode, (4", (10.16 cm), E1450-NSB Edge Insulated Needle Electrode, (2.8", (7.2 cm), E1465 Edge™ Button Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2450HS Edge™ Rocker Switch Pencil Blade Electrode, Holster, E2350HDB Valleylab™ Angled Micro-Needle Electrode, 45 degree, 3 mm from tip, 3 cm, E1652 Edge Hex-locking Blade Electrode, (2.5” (, 6.35 cm), E1450X and E1450XNSB Edge Insulated Blade Electrode, Safety Sleeve, (2.75" (, 7 cm), E1455B Edge Insulated Needle Electrode, 6.5" (16.51 cm), E1465-6 Edge Insulated Blade Electrode, Safety Sleeve, (4", (10.16 cm), E1455B-4NSB Edge Insulated Needle Electrode, Safety Sleeve, (4", (10.16 cm), E1465B-4 Edge Rocker Switch Pencil Blade Electrode, Holster, E2350HDBNSB Edge Needle Electrode, (2.8", (7.2 cm), E1452NSB Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HDBNSB Edge Insulated Blade Electrode, (2.75", (7 cm), E1455 Valleylab™ Angled Micro-Needle Electrode, 45 degree, 1 cm from tip, 3 cm, E1653 Edge™ Button Switch Pencil Blade Electrode, Holster, E2450H Edge Needle Electrode, (2.8" (, 7.2 cm), E1452 Edge™ Button Switch Pencil Blade Electrode, Holster, E2450HNSB Edge™ Pencil Blade Electrode, Holster, E2250HNSB Valleylab™ Straight Micro-Needle Electrode, 3 cm, E1651 Edge™ Pencil Blade Electrode, Holster, E2250H Edge Blade Electrode, (6.5" (, 16.51 cm), E1450-6 and E1450-6NSB Edge™ Rocker Switch Pencil Blade Electrode, Holster, Smoke Attachment, E2350HS Edge Insulated Needle Electrode, Safety Sleeve, (2.8", (7.2 cm), E1465B and E1465BNSB Argyle Dialysis Catheter Accessories MAHURKAR Elite Acute Dual Lumen Catheters, Kits, and Trays MAHURKAR Elite Acute Triple Lumen Catheters, Kits, and Trays CT9000

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Reprocess Single-Use Device