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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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UltraPoint™ - 10816843024236

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 28 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE ORANGE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016383
Not in Commercial Distribution

  • 10816843024243 ()
  • 10816843024236 ()


  • Electromyographic needle electrode, single-use

Rochester - 10816843020009

REUSABLE TIN SKIN PICK-UP DISC ELECTRODES: 9 MM TIN DISC, RED & BLACK, 2 FT. (0.61 M), TWISTED WIRE
ROCHESTER ELECTRO-MEDICAL, INC.
032238
Not in Commercial Distribution

  • 10816843020009 ()


  • Analytical non-scalp cutaneous lead

GoldSelect™ - 10816843024403

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE, MVAP LABEL
ROCHESTER ELECTRO-MEDICAL, INC.
DGE-60
Not in Commercial Distribution

  • 10816843024403 ()
  • 10816843024397 ()


  • Analytical scalp electrode, single-use

UltraPoint™ - 10816843024359

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 26 GA., 50 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE GREEN LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016395
Not in Commercial Distribution

  • 10816843024366 ()
  • 10816843024359 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024311

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 50 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016391
Not in Commercial Distribution

  • 10816843024328 ()
  • 10816843024311 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024274

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 27 GA., 25 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE BLUE LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016386
Not in Commercial Distribution

  • 10816843024281 ()
  • 10816843024274 ()


  • Electromyographic needle electrode, single-use

UltraPoint™ - 10816843024212

TE: DISPOSABLE ULTRAPOINT MONOPOLAR NEEDLE ELECTRODES: 29 GA., 37 MM NEEDLE, 2.5 FT. (0.76 M) SINGLE RED LEADWIRE
ROCHESTER ELECTRO-MEDICAL, INC.
016380
Not in Commercial Distribution

  • 10816843024229 ()
  • 10816843024212 ()


  • Electromyographic needle electrode, single-use

GoldSelect™ - 10816843020238

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 6 FT. (1.8 M), SINGLE, PVC WIRE (25/PACK)
ROCHESTER ELECTRO-MEDICAL, INC.
003772-25
Not in Commercial Distribution

  • 10816843020238 ()
  • 10816843020245 ()


  • Analytical scalp electrode, single-use

GoldSelect™ - 10816843020191

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 5 FT. (1.5 M), SINGLE, PVC WIRE (25/PACK)
ROCHESTER ELECTRO-MEDICAL, INC.
003760-25
Not in Commercial Distribution

  • 10816843020191 ()
  • 10816843020207 ()


  • Analytical scalp electrode, single-use

GoldSelect™ - 10816843020153

DISPOSABLE GOLDSELECT CUP ELECTRODES: 9 MM STAMPED GOLD DISC, 4 FT. (1.2 M), SINGLE, PVC WIRE (25/PACK)
ROCHESTER ELECTRO-MEDICAL, INC.
003748-25
Not in Commercial Distribution

  • 10816843020153 ()
  • 10816843020160 ()


  • Analytical scalp electrode, single-use

CONMED Buffalo Filter - 20845854080907

Smoke Evacuation Tubing 1-3/8 in (35 mm) x 6 ft (1.8 m) tube with wand & sponge guard
Conmed Corporation
VTWT505
In Commercial Distribution

  • 30845854080904 ()
  • 20845854080907 ()
  • 00845854080903 ()
  • 00851136002518 ()
VTWT505

  • Surgical plume evacuation system tube

HUDSON RCI - 14026704643001

MICRO MIST® Nebulizer, with Tee, 7 ft. (2.1m) Star Lumen® Tubing, ClearConnect®, Mouthpiece and Reservoir
TELEFLEX INCORPORATED
IPN049707
In Commercial Distribution

  • 34026704643005 ()
  • 14026704643001 ()
1883CC

  • Benchtop nebulizer, non-heated

Hudson RCI - 14026704642981

Pediatric SofTech PLUS® Nasal Cannula with 14 ft. (4.2 m) Green Star Lumen® Tubing, ClearConnect™
TELEFLEX INCORPORATED
IPN049705
In Commercial Distribution

  • 34026704642985 ()
  • 14026704642981 ()
1878CC

  • Nasal oxygen cannula, carbon-dioxide-sampling

Hudson RCI - 14026704642974

Adult SofTech PLUS® Nasal Cannula with 14 ft. (4.2 m) Green Star Lumen® Tubing, ClearConnect™
TELEFLEX INCORPORATED
IPN049704
In Commercial Distribution

  • 34026704642978 ()
  • 14026704642974 ()
1877CC

  • Nasal oxygen cannula, carbon-dioxide-sampling

Hudson RCI - 14026704642967

Neonate SofTech PLUS® Nasal Cannula with 7 ft. (2.1 m) Green Star Lumen® Tubing, ClearConnect™
TELEFLEX INCORPORATED
IPN049703
In Commercial Distribution

  • 34026704642961 ()
  • 14026704642967 ()
1873CC

  • Nasal oxygen cannula, carbon-dioxide-sampling

Hudson RCI - 14026704642950

Infant SofTech PLUS® Nasal Cannula with 7 ft. (2.1 m) Green Star Lumen® Tubing, ClearConnect™
TELEFLEX INCORPORATED
IPN049702
In Commercial Distribution

  • 34026704642954 ()
  • 14026704642950 ()
1872CC

  • Nasal oxygen cannula, carbon-dioxide-sampling

Hudson RCI - 14026704642943

Pediatric SofTech PLUS® Nasal Cannula with 7 ft. (2.1 m) Green Star Lumen® Tubing, ClearConnect™
TELEFLEX INCORPORATED
IPN049701
In Commercial Distribution

  • 34026704642947 ()
  • 14026704642943 ()
1871CC

  • Nasal oxygen cannula, carbon-dioxide-sampling

Hudson RCI - 14026704642936

Adult SofTech PLUS® Nasal Cannula with 7 ft. (2.1 m) Green Star Lumen® Tubing, ClearConnect™
TELEFLEX INCORPORATED
IPN049700
In Commercial Distribution

  • 34026704642930 ()
  • 14026704642936 ()
1870CC

  • Nasal oxygen cannula, carbon-dioxide-sampling

HUDSON RCI - 14026704657084

STAR LUMEN® Tubing Five-Channel Low-Pressure Medical Gas Supply Tubing 15 m (50 ft. ) Length with Universal Connector
TELEFLEX INCORPORATED
IPN913977
In Commercial Distribution

  • 24026704657081 ()
  • 14026704657084 ()
  • 04026704596027 ()
1928

  • Oxygen administration tubing

ICU Medical - 00840619070601

Cath Lab w/5 Port "OFF" Manifold (600 psi), 72" Admin Set and 4 ft Transpac™ IV
ICU MEDICAL, INC.
46100-91
In Commercial Distribution

  • 10840619070608 ()
  • 00840619070601 ()
46100-91

  • Angiography kit

Multi-Link™ - 10889483573679

Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, IEC, Round Connector, 2.4 m/8 ft
AirLife Finland Oy
1554BAO
In Commercial Distribution

1554BAO

  • Electrocardiographic lead set, reusable

Multi-Link™ - 10889483573662

Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Round Connector, 2.4 m/8 ft
AirLife Finland Oy
1554AAO
In Commercial Distribution

1554AAO

  • Electrocardiographic lead set, reusable

Multi-Link™ - 10889483573655

Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Rectangular Connector, 2.4 m/8 ft
AirLife Finland Oy
1553AAO
In Commercial Distribution

1553AAO

  • Electrocardiographic lead set, reusable

Vital Signs™ - 10889483576274

Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Dual, 3.6 m/12 ft.
AirLife Finland Oy
2021197-003
In Commercial Distribution

2021197-003

  • Electrical-only medical device connection cable, reusable

Vital Signs™ - 10889483576250

Vital Signs™ Invasive Blood Pressure Cable For Use with Edwards Lifesciences TruWave, Single, 3.6 m/12 ft.
AirLife Finland Oy
2021197-001
In Commercial Distribution

2021197-001

  • Electrical-only medical device connection cable, reusable

Vital Signs™ - 10889483575772

Vital Signs™ Invasive Blood Pressure Cable For Use with Utah/Biotrans™, Dual, 3.6 m/12 ft.
AirLife Finland Oy
2016997-003
In Commercial Distribution

2016997-003

  • Electrical-only medical device connection cable, reusable

Vital Signs™ - 10889483575758

Vital Signs™ Invasive Blood Pressure Cable For Use with Utah/biotrans™, Single 3.6 m/12 ft.
AirLife Finland Oy
2016997-001
In Commercial Distribution

2016997-001

  • Electrical-only medical device connection cable, reusable

Vital Signs™ - 10889483591437

Vital Signs™ cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
AirLife Finland Oy
9446-910
In Commercial Distribution

9446-910

  • Injectate temperature probe

Multi-Link™ - 10190752109575

Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Rectangular Connector, 2.4 m/ 8 ft
AIRLIFE
1553AAO
In Commercial Distribution

  • 10190752109575 ()


  • Electrocardiographic lead set, reusable

Multi-Link™ - 10190752182158

Multi-Link™ Maternal ECG Cable and 3-Leadwire Set for Corometrics™, AHA, Round Connector, 2.4 m/ 8 ft
AIRLIFE
1554AAO
In Commercial Distribution



  • Electrocardiographic lead set, reusable
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