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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ZIP Pen Ergonomic Smoke Evacuation Pencil, E-Z Clean, Non-Stick, PTFE Coated, 10 Ft (3.04m) Tubing
MEGADYNE MEDICAL PRODUCTS, INC.
2525-10
Not in Commercial Distribution

  • 30614559104044 ()
  • 10614559104040 ()


  • Electrosurgical system generator
Electrosurgical Pencil Rocker Switch E-Z Clean Coated Modified Blade Electrode 10 ft (3 m) cord
MEGADYNE MEDICAL PRODUCTS, INC.
0036
In Commercial Distribution

  • 10614559101810 ()
  • 30614559101814 ()
0036

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical Pencil Button Switch E-Z Clean Coated Modified Blade Electrode 10 ft (3 m) cord
MEGADYNE MEDICAL PRODUCTS, INC.
0037
In Commercial Distribution

  • 10614559101667 ()
  • 30614559101661 ()
0037

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical Pencil Button Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord Holster
MEGADYNE MEDICAL PRODUCTS, INC.
0035H
In Commercial Distribution

  • 10614559100493 ()
  • 30614559100497 ()
0035H

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Electrosurgical Pencil Rocker Switch E-Z Clean Coated Blade Electrode 10 ft (3 m) cord Holster
MEGADYNE MEDICAL PRODUCTS, INC.
0030H
In Commercial Distribution

  • 10614559100479 ()
  • 30614559100473 ()
0030H

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
"Warming Cabinet Single Compartment (Glass Door) / 29"" x 28"" x 74"", 19.8 CU. FT/PI3"
Imperial Surgical Ltd
OR-8854
In Commercial Distribution

  • 07540162040146 ()
OR-8854

  • Multi-purpose warming cabinet, stationary
"Warming Cabinet Single Compartment (SS Door) / 29"" x 28"" x 74"", 19.8 CU. FT/PI3"
Imperial Surgical Ltd
OR-7854
In Commercial Distribution

  • 07540162040139 ()
OR-7854

  • Multi-purpose warming cabinet, stationary
"Warming Cabinet Single Compartment (Glass Door) / 29"" x 22"" x 74"", 14.6 CU. FT/PI3"
Imperial Surgical Ltd
OR-8754
In Commercial Distribution

  • 07540162040122 ()
OR-8754

  • Multi-purpose warming cabinet, stationary
"Warming Cabinet Single Compartment (SS Door) / 29"" x 22"" x 74"", 14.6 CU. FT/PI3"
Imperial Surgical Ltd
OR-7754
In Commercial Distribution

  • 07540162040115 ()
OR-7754

  • Multi-purpose warming cabinet, stationary
AMSure® Non-Rebreather Oxygen Mask ADULT with 7 ft. (213 cm) Star Tubing, Reservoir Bag
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411008140 ()
  • 10704411008149 ()
AS75010

  • Non-rebreathing oxygen face mask
Transpac™ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK
ICU MEDICAL, INC.
46104-35
In Commercial Distribution

  • 10887709050799 ()
  • 00887709050792 ()
46104-35

  • Invasive blood pressure transducer set
PowerPICC SOLO2 FT Catheter with Sherlock Tip Location System (TLS) Stylet 5F Full Tray (Dual-Lumen)
Bard Access Systems, Inc.
9295108F
In Commercial Distribution

  • 10801741035774 ()
  • 00801741035777 ()

  • Catheter Gauge: 5 French
  • Length: 55 Centimeter
9295108F

  • Peripherally-inserted central venous catheter
Infinity Series Blood Bank Refrigerator, upright 25 cu. ft., left hinge, door heater, glass door
FOLLETT CORPORATION
REF25i-BB-LHT00G
In Commercial Distribution

  • 00857117006735 ()
01525864

  • Blood refrigerator
Infinity Series Blood Bank Refrigerator, upright 20 cu. ft., right hinge, door heater, glass door
FOLLETT CORPORATION
REF20i-BB-RHT00G
In Commercial Distribution

  • 00857117006698 ()
01525575

  • Blood refrigerator
Infinity Series Blood Bank Refrigerator, upright 20 cu. ft., left hinge, door heater, glass door
FOLLETT CORPORATION
REF20i-BB-LHT00G
In Commercial Distribution

  • 00857117006650 ()
01525534

  • Blood refrigerator
Infinity Series Blood Bank Refrigerator, upright 25 cu. ft., right hinge, door heater, glass door
FOLLETT CORPORATION
REF25i-BB-RHT00G
In Commercial Distribution

  • 00857117006773 ()
01525906

  • Blood refrigerator
3 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer
PRECISION BIOMETRICS INC
PB-202
In Commercial Distribution

  • 00853818007323 ()
PB-202

  • Medical device USB cable
6 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer
PRECISION BIOMETRICS INC
PB-200
In Commercial Distribution

  • 00853818007187 ()


  • Medical device USB cable
10 inch Potts-Smith Monopolar Forcep, Serrated, Straight Tip, 0.5mm Tip, with 10 ft Cable attached
Surgical Direct, Inc.
SD8011-104
In Commercial Distribution

  • B382SD80111040 ()
SD8011-104

  • Endoscopic electrosurgical handpiece/electrode, bipolar, reusable
Curaplex Bag Valve Mask (BVM), Infant, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
BOUND TREE MEDICAL, LLC
30072MS
In Commercial Distribution

  • 00817617024363 ()
  • 00817617024233 ()
30072MS

  • Pulmonary resuscitator, manual, single-use
Curaplex Bag Valve Mask (BVM), Pediatric, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
BOUND TREE MEDICAL, LLC
30071
In Commercial Distribution

  • 00817617024356 ()
  • 00817617024226 ()
30071

  • Pulmonary resuscitator, manual, single-use
Curaplex Bag Valve Mask (BVM), Adult, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
BOUND TREE MEDICAL, LLC
30070
In Commercial Distribution

  • 00817617024349 ()
  • 00817617024219 ()
30070

  • Pulmonary resuscitator, manual, single-use
TWINFIX 5.5 MM PK FT ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, WHITE ULTRABRAID, STERILE
Smith & Nephew, Inc.
72201576
In Commercial Distribution

  • 03596010001818 ()
72201576

  • Tendon/ligament bone anchor, non-bioabsorbable
High Transmission Autoclavable Fiberoptic Light Guide Snap On 4 mm, 7 Ft Long (213 cm)
Gyrus ACMI, LLC
G93
In Commercial Distribution

  • 00821925001541 ()


  • Rigid optical ureteroscope
Collection Set, Disposable with Handle and Tapered Fittings Tubing, 6 Ft (183 cm) (10/PK)
Gyrus ACMI, LLC
23116
In Commercial Distribution

  • 00821925004184 ()
  • 00821925030954 ()


  • Surgical suction system collection container, single-use
TWINFIX 6.5 MM PK FT ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK, STERILE
Smith & Nephew, Inc.
72201682
In Commercial Distribution

  • 03596010604767 ()
72201682

  • Tendon/ligament bone anchor, non-bioabsorbable
TWINFIX 6.5 MM PK FT ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, WHITE ULTRABRAID, STERILE
Smith & Nephew, Inc.
72201681
In Commercial Distribution

  • 03596010604750 ()
72201681

  • Tendon/ligament bone anchor, non-bioabsorbable
TWINFIX 5.5 MM PK FT ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK, STERILE
Smith & Nephew, Inc.
72201577
In Commercial Distribution

  • 03596010604729 ()
72201577

  • Tendon/ligament bone anchor, non-bioabsorbable
Curaplex Bag Valve Mask (BVM), Infant, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
BOUND TREE MEDICAL, LLC
30072MS
In Commercial Distribution

  • 00815277025393 ()
  • 00815277025386 ()

  • Total Volume: 280 Milliliter


  • Pulmonary resuscitator, manual, single-use
Curaplex Bag Valve Mask (BVM), Pediatric, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
BOUND TREE MEDICAL, LLC
30071
In Commercial Distribution

  • 00815277025379 ()
  • 00815277025362 ()

  • Total Volume: 450 Milliliter


  • Pulmonary resuscitator, manual, single-use
Curaplex Bag Valve Mask (BVM), Adult, incl Mask, Oxygen Reservoir, 7 ft Tubing 12ea/cs
BOUND TREE MEDICAL, LLC
30070
In Commercial Distribution

  • 00815277025355 ()
  • 00815277025348 ()

  • Total Volume: 1500 Milliliter


  • Pulmonary resuscitator, manual, single-use
Cardiac output in-line injectate probe for GE monitors, ICU Medical Thermoset, 2.4 m/8 ft
Carefusion Finland 320 Oy
9446-913
Not in Commercial Distribution

  • 10885403258381 ()
9446-913

  • Injectate temperature probe
Cardiac output in-line injectate probe for GE monitors, Edwards CO set, 0.9 m/3 ft
Carefusion Finland 320 Oy
9446-910
Not in Commercial Distribution

  • 10885403258374 ()
9446-910

  • Injectate temperature probe
Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Single, 1.2 m/4 ft
Carefusion Finland 320 Oy
2021196-002
Not in Commercial Distribution

  • 10885403256387 ()
2021196-002

  • Electrical-only medical device connection cable, reusable
Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Dual, 1.2 m/4 ft
Carefusion Finland 320 Oy
2021196-004
Not in Commercial Distribution

  • 10885403256332 ()
2021196-004

  • Electrical-only medical device connection cable, reusable
Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Dual, 1.2 m/4 ft
Carefusion Finland 320 Oy
2021197-004
Not in Commercial Distribution

  • 10885403256318 ()
2021197-004

  • Electrical-only medical device connection cable, reusable
Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Single, 1.2 m/4 ft
Carefusion Finland 320 Oy
2021197-002
Not in Commercial Distribution

  • 10885403256301 ()
2021197-002

  • Electrical-only medical device connection cable, reusable
Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Dual, 3.6 m/12 ft
Carefusion Finland 320 Oy
2021196-003
Not in Commercial Distribution

  • 10885403256295 ()
2021196-003

  • Electrical-only medical device connection cable, reusable
Invasive Blood Pressure Cable, For use with ICU Medical TRANSPAC-IV, Single, 3.6 m/12 ft
Carefusion Finland 320 Oy
2021196-001
Not in Commercial Distribution

  • 10885403256288 ()
2021196-001

  • Electrical-only medical device connection cable, reusable
Invasive Blood Pressure Cable, For use with EDWARDS LS TRUWAVE, Dual, 3.6 m/12 ft
Carefusion Finland 320 Oy
2021197-003
Not in Commercial Distribution

  • 10885403256028 ()
2021197-003

  • Electrical-only medical device connection cable, reusable
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