Covidien

FDA Device Registration & Listing · TIJUANA, B.C. Mexico, MX · Registration 9610849

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9610849
FEI Number
3002807391
Entity Name
Covidien
City/State/Country
TIJUANA, B.C. Mexico, MX
Establishment Address
Boulevard Insurgentes 19030 Libramiento, TIJUANA, B.C. Mexico 22225, MX
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Covidien llc (Owner Number: 1282497)
Owner / Operator Contact Address
15 HAMPSHIRE STREET, --, Mansfield, MA 02048, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered 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) 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 Argyle Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Stencil Argyle Pediatric Peritoneal Dialysis Catheter Argyle Neonatal Peritoneal Dialysis Catheter Argyle Peritoneal Dialysis Catheter Kit 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 Argyle Peritoneal Dialysis Accessory 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 Needle Electrode Valleylab Fine -Needle Electrode, Reusable, 2.6" (6.6 cm),E1003 Valleylab Ball Electrode Valleylab Blade Electrode Valleylab Straight Extension, 34.3 cm, E1504 Valleylab Hex-locking Blade Electrode, 2.4" (6.2 cm),E1551XNSB Valleylab Straight Extension, 13 cm, E1502 Valleylab Tungsten Loop Electrode, Reusable, 9.5 mm,E1005 Valleylab Ball Electrode, 6.5" (16.51 cm), E1551-6NSB Valleylab Needle Electrode, 2.8" (7.2 cm), E1552NSB Valleylab Ball Electrode, Reusable, 3.2 mm, E1000 Valleylab Ball Electrode, Reusable, 5.6 mm, E1002 Valleylab Ball Electrode, 5 mm, E1550 Valleylab Needle Electrode, 2.8" (7.2 cm), E1552 ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter Argyle Faller Tunneling Trocar Handifil ClosureFast Endovenous Radiofrequency Ablation (RFA) Catheter Microvascular Plug 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 Argyle Peritoneal Dialysis Accessory 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 Ritus 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-17
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2022-04-27
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2000-05-02
DQA Oximeter Cardiovascular Class 2 870.2700 2018-09-07
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2018-11-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-04-06
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-04-06
FEB Accessories, Cleaning, For Endoscope Gastroenterology, Urology Class 2 876.1500 2007-04-24
CAI Circuit, Breathing (W Connector, Adaptor, Y Piece) Anesthesiology Class 1 868.5240 2008-02-27
DRB Stylet, Catheter Cardiovascular Class 2 870.1380 2008-01-17
GDT Staple, Removable (Skin) General, Plastic Surgery Class 1 878.4760 2007-12-10
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2008-02-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
FMI Needle, Hypodermic, Single Lumen General Hospital Class 2 880.5570 2008-06-20
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2008-02-25
NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-22
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2020-01-22
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-20
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2008-02-26
DQA Oximeter Cardiovascular Class 2 870.2700 2008-02-26
DQA Oximeter Cardiovascular Class 2 870.2700 2008-02-28
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-06-17
FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) Gastroenterology, Urology Class 2 876.5130 2021-05-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2020-12-02
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-26
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days General Hospital Class 2 880.5200 2014-06-30
DQA Oximeter Cardiovascular Class 2 870.2700 2008-02-28
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2008-02-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
DPZ Oximeter, Ear Cardiovascular Class 2 870.2710 2008-03-28
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-16
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2008-02-26
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
PXI Thoracentesis Tray General Hospital Class 2 880.5570 2019-02-01
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2009-05-11
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2008-02-26
KNT Tubes, Gastrointestinal (And Accessories) Gastroenterology, Urology Class 2 876.5980 2008-06-17
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 1996-09-05
LZH Pump, Infusion, Enteral General Hospital Class 2 880.5725 2008-01-11
KOD Catheter, Urological Gastroenterology, Urology Class 2 876.5130 2007-12-17
DQA Oximeter Cardiovascular Class 2 870.2700 2022-06-22
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-04-12
MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology Class 2 876.5540 2008-01-16
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2008-02-14
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2009-05-12
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-17
DRS Transducer, Blood-Pressure, Extravascular Cardiovascular Class 2 870.2850 2008-10-30
DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular Class 2 870.1310 2008-01-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
PEV Dialysis Administration Kit Gastroenterology, Urology Class 2 876.5820 2018-12-05
LDQ N/A N/A Class N/A N/A 2008-06-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-04-12
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-16
DQX Wire, Guide, Catheter Cardiovascular Class 2 870.1330 2014-06-30
DQA Oximeter Cardiovascular Class 2 870.2700 2008-03-07
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2008-02-26
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-02-28
OJS Tourniquet Kit General, Plastic Surgery Class 1 878.5900 2019-02-01
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 1992-06-29
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2007-12-11
NFK Kit, Repair, Catheter, Hemodialysis Gastroenterology, Urology Class 2 876.5540 2010-08-11
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2010-08-11
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2009-05-12
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2008-10-30
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-12-11
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-06-30
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-17
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2009-05-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-03-22
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-04-12
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-30
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-04-20
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2008-10-30
FMG Stopcock, I.V. Set General Hospital Class 2 880.5440 2008-02-28
FJS Catheter, Peritoneal, Long-Term Indwelling Gastroenterology, Urology Class 2 876.5630 2008-01-17
DQA Oximeter Cardiovascular Class 2 870.2700 2012-03-27
DSA Cable, Transducer And Electrode, Patient, (Including Connector) Cardiovascular Class 2 870.2900 2012-03-27
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2012-03-27
FKO Catheter, Peritoneal Dialysis, Single Use Gastroenterology, Urology Class 2 876.5630 2014-06-30
DWJ System, Thermal Regulating Cardiovascular Class 2 870.5900 2008-02-14
MSD Catheter, Hemodialysis, Implanted Gastroenterology, Urology Class 2 876.5540 2013-02-06
NYU Catheter, Hemodialysis, Implanted, Coated Gastroenterology, Urology Class 2 876.5540 2013-02-06
BTM Ventilator, Emergency, Manual (Resuscitator) Anesthesiology Class 2 868.5915 2008-02-28
KGZ Accessories, Catheter General, Plastic Surgery Class 1 878.4200 2008-06-17

Official Correspondent

No official correspondent registered.

US Agent Details

Kae Miller Email: kae.miller@medtronic.com Phone: (303) 4081427

Related Public Records

Same Entity

Covidien llc
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8020889 Mallinckrodt Medical ATHLONE Westmeath, IE
3006451981 Covidien Medical Products (Shanghai) Manufacturing LLC Shanghai, CN
8044004 ORIDION MEDICAL 1987 LTD. JERUSALEM, IL
1282497 Covidien LLC MANSFIELD, MA, US
9681384 Covidien Ciudad Juarez Chihuahua, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K112536 Covidien SONICISION STERILIZATION TRAY 2012-04-19
K142547 Covidien Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm 2014-12-09
K130320 Covidien BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW 2014-02-04
K241486 Covidien Sofsilk™ Coated Braided Silk Suture 2024-12-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024 Covidien 1
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0021-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019 Oridion Medical 1987 Ltd. Har Hotzvim Industrial 2
CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9610849. Last updated year: 2026. Please use registration number 9610849 when referencing this establishment in official correspondence.
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