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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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UNO Pump 7 Day Rechargeable - 00849405001607

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S00R4
In Commercial Distribution

  • 00849405001607 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 30 Therapy Kit 10x10 - 00849405001478

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-6
In Commercial Distribution

  • 00849405001478 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 7 Therapy Kit 10x10 - 00849405000549

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-4
In Commercial Distribution

  • 00849405000549 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 15 Therapy Kit 10x10 - 00849405000532

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1010-5
In Commercial Distribution

  • 00849405000532 ()


  • Negative-pressure wound therapy system, electric, single-use

Adventure Medical Kits - 00707708100161

Mountain Series Daytripper Bandage Materials 5 - Bandage, Adhesive, Fabric, 1" x 3" 3 - Bandage, Adhesive, Fabric, Knuckle 4 - Bandage, Butterfly Closure 2 - Dressing, Gauze, Sterile, 2" x 2", Pkg./2 2 - Dressing, Gauze, Sterile, 4" x 4", Pkg./2 2 - Dressing, Non-Adherent, Sterile, 2" x 3" Bleeding 1 - Gloves, Nitrile (Pair), Hand Wipe 1 - Trauma Pad, 5" x 9" Blister / Burn 1 - Moleskin, Pre-Cut & Shaped (14 pieces) Fracture / Sprain 1 - Bandage, Elastic with Velcro, 2" Instrument 2 - Safety Pins 1 - Splinter Picker/Tick Remover Forceps Medical Information 1 - Comp. Guide to Wilderness & Travel Medicine Medication 2 - After Bite Wipe 2 - Antihistamine (Diphenhydramine 25 mg) 2 - Aspirin (325 mg), Pkg./2 2 - Diamode (Loperamide HCI 2 mg), Pkg./1 3 - Ibuprofen (200 mg), Pkg./2 Wound Care 4 - Antiseptic Wipe 2 - Alcohol Swab 1 - Cotton Tip Applicator, Pkg./2 1 - Syringe, Irrigation, 10 cc, 18 Gauge Tip 1 - Tape, 1" x 10 Yards 1 - Skin Tac Adhesive Wipes 3 - Triple Antibiotic Ointment, Single Use
Adventure Ready Brands
1
In Commercial Distribution

  • 00707708100161 ()
0100-0116

  • First aid kit, medicated

Angios Classic Angiographic Convenience Kit - 00885672103392

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0442
In Commercial Distribution

  • 00885672103392 ()

  • Flow Rate: JR: 32 mL/sec, JL: 29 mL/sec, PT: 33 mL/sec
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • JL 4.0/120 cm, JR 4.0/120 cm, Pigtail 145°/120 cm
  • Pigtail Side Holes: 5
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
ANG4-0442

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101916

Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0240
In Commercial Distribution

  • 00885672101916 ()

  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Pigtail Side Holes: 5
  • Flow Rate: JR: 28 mL/sec, JL: 28 mL/sec, PT: 29 mL/sec
ANG4-0240

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101909

Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0239
In Commercial Distribution

  • 00885672101909 ()

  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Flow Rate: JR: 28 mL/sec, JL: 28 mL/sec, PT: 30 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Maximum Recommended Guidewire 0.038 in
ANG4-0239

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101893

Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0040
In Commercial Distribution

  • 00885672101893 ()

  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 28 mL/sec, JL: 29 mL/sec, PT: 29 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Recommended Pressure Limit: 1200 psi max.
  • Maximum Recommended Guidewire 0.038 in
  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
ANG4-0040

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101886

Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0039
In Commercial Distribution

  • 00885672101886 ()

  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 28 mL/sec, JL: 29 mL/sec, PT: 31 mL/sec
  • JL 4.0/100 cm, JR 4.0/100 cm, Straight Pigtail/110 cm
  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
ANG4-0039

  • Angiographic catheter, single-use
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