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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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Warming Blanket, Adult Tube Underbody 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3831
In Commercial Distribution

  • 00811220031817 ()
  • 10811220031814 ()
3831

  • Blanket warming cabinet, dry-heat
Warming Blanket, Extended Upper Torso Arms Out 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3829
In Commercial Distribution

  • 10811220031807 ()
  • 00811220031800 ()
3829

  • Blanket warming cabinet, dry-heat
Warming Blanket, Extended Upper Torso Arms In 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3828
In Commercial Distribution

  • 10811220031791 ()
  • 00811220031794 ()
3828

  • Blanket warming cabinet, dry-heat
Warming Blanket, Extended Lower Body Blanket 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3827
In Commercial Distribution

  • 10811220031784 ()
  • 00811220031787 ()
3827

  • Blanket warming cabinet, dry-heat
Warming Blanket, Extended Full Torso 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3826
In Commercial Distribution

  • 10811220031777 ()
  • 00811220031770 ()
3826

  • Blanket warming cabinet, dry-heat
Warming Blanket, Upper Body Arms Out 57 x 196 cm 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3824
In Commercial Distribution

  • 10811220031760 ()
  • 00811220031763 ()
3824

  • Blanket warming cabinet, dry-heat
Warming Blanket, Upper Body Arms In 100 x 124 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3823
In Commercial Distribution

  • 10811220031753 ()
  • 00811220031756 ()
3823

  • Blanket warming cabinet, dry-heat
Warming Blanket, Lower Body 100 x 120 cm 1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3822
In Commercial Distribution

  • 00811220031749 ()
  • 10811220031746 ()
3822

  • Blanket warming cabinet, dry-heat
Warming Blanket, Full Body 100 x 195 cm 1.    GENERAL DESCRIPTION ·         PremierPro™ Multi-functional Warming Blankets 2.    CONSTRUCTION ·         Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric ·         Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) ·         White (patient facing) Layer - Perforated to enable passage of air and temperature control ·         Disposable / Single Patient Use ·         Not made with natural rubber latex. 3.    MRI COMPATIBLE ·         Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.
SVS LLC
3821
In Commercial Distribution

  • 10811220031739 ()
  • 00811220031732 ()
3821

  • Blanket warming cabinet, dry-heat
Overall size 30”W x 26.5”D x 74.5”T. 21 Cubic ft. storage Chamber I.D. 26”W x 23”D x 61”T. Temperature Range: 90-160 F Accuracy +/- 3 degrees F of set point 2 Adjustable shelves 1 Fixed shelf Digital control Glass door Data logger Door lock Keyed temperature lock Audible and visual over-temp alarm Foot levelers Mobile Base Electrical: 120V, 7.5 Amp, 50/60 Hz .53 kw/hr, 1810 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
WB2630TS-G-MB
In Commercial Distribution

  • B286WB2630TSGMB1 ()
WB2630TS-G-MB

  • Blanket warming cabinet, dry-heat
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