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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AIR SUPPLY Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING Disposable Models The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3703
In Commercial Distribution

  • 10818566019193 ()
  • 00818566019196 ()

  • Length: 50 Inch
3703

  • Patient transfer system, powered
AIR SUPPLY Air supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING Disposable Models The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3702
In Commercial Distribution

  • 00818566019189 ()
  • 10818566019186 ()

  • Length: 39 Inch


  • Patient transfer system, powered
INTENDED USE/ CONTRAINDICATIONS PrernierPro'" Air Transfer Mats are indicated for patients • Who are unable to transfer or turn by their own effort. both assisted and unassisted • Whose size and weight present possible risks to caregivers involved in the transfer of the patient PRECAUTIONS & WARNINGS • Use two or more caregivers during patient transfers • Do not use transfer mat until user manual is reviewed. • Do not leave patient unattended on inflated transfer mat • Do not attempt to move patient on uninflated transfer mat. • The maximum safe working load for all PremierPro"' Air Transfer Mats is 1,000Ibs (450kg) AIR SUPPLY Air supply units may be compatible with PremierPro' " Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit’s operating Instructions, observing all precautions and warnings. All safety guidelines within the air supply unit' s operating Instructions should be followed. INSTRUCTIONS FOR USE 1. Transfer surfaces should be close together and equal height or a slightly lower destination surface. 2. Air inlet pockets are located at the foot end of pad. Locate and insert air supply hose. 3. Avoid having obstructions in path of transfer including lines and hoses 4. Hold onto handles during inflation. 5. Move patient in a diagonal direction. head or feet end first until patient reaches destination and is centered. 6. Raise side rails, disconnect t air hose and undo safety straps. 7. Use appropriate turning and rolling technique to remove transfer mat from underneath patient.
SVS LLC
3701
In Commercial Distribution

  • 10818566019179 ()
  • 00818566019172 ()

  • Length: 34 Inch
3701

  • Patient transfer system, powered
INTENDED USE/ CONTRAINDICATIONS PremierPro™ Air Transfer Mats are indicated for patients: Who are unable to transfer or turn by their own effort, both assisted and unassisted. Whose size and weight present possible risks to caregivers involved in the transfer of the patient. PRECAUTIONS & WARNINGS Use two or more caregivers during patient transfers. Do not use transfer mat until user manual is reviewed. Do not leave patient unattended on inflated transfer mat. Do not attempt to move patient on uninflated transfer mat. The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg). AIR SUPPLY Air supply units may be compatible with Premier™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed. MRI SAFETY PremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. Safety strap buckles are constructed from Polypropylene. Air supply fasteners are manufactured from non-ferrous metal. Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts. Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI. CLEANING The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
SVS LLC
3700
In Commercial Distribution

  • 00818566019165 ()
  • 10818566019162 ()

  • Length: 28 Inch
3700

  • Patient transfer system, powered
No Description
Ouraring Inc.
Fertile Window iOS
In Commercial Distribution

  • 06430060159990 ()


  • Menstrual cycle self-monitoring software
No Description
Ouraring Inc.
Fertile Window Android
In Commercial Distribution

  • 06430060159983 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking iPhone App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312529 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking Watch App (Version 4.0)
APPLE INC.
Feature Version 4.x
In Commercial Distribution

  • 00194253312512 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking iPhone App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845974 ()


  • Menstrual cycle self-monitoring software
Cycle Tracking Watch App (Version 3.0)
APPLE INC.
Feature Version 3.x
In Commercial Distribution

  • 00194252845967 ()


  • Menstrual cycle self-monitoring software
No Description
Naturalcycles Nordic AB
1.0.0.002
In Commercial Distribution

  • 07350014630100 ()


  • Menstrual cycle self-monitoring software
Pack includes: Twisted Her Pleasure Sensations Intense Her Pleasure Warming Sensations
CHURCH & DWIGHT CO., INC.
00022600953029
In Commercial Distribution

  • 00022600953029 ()
  • 80022600953025 ()


  • Basic male condom, Hevea-latex
MIRAGE FX FOR HER
RESMED PTY LTD
62109
In Commercial Distribution

  • 00619498621095 ()
62109

  • CPAP/BPAP nasal mask, reusable
MIRAGE FX FOR HER HEADGEAR
RESMED PTY LTD
62129
In Commercial Distribution

  • 00619498621293 ()
62129

  • CPAP/BPAP nasal mask, reusable
AirSense 10 AutoSet For Her
RESMED PTY LTD
37405
In Commercial Distribution

  • 00619498374052 ()
37405

  • Home CPAP unit
AirSense 10 AutoSet For Her
RESMED PTY LTD
37404
In Commercial Distribution

  • 00619498374045 ()
37404

  • Home CPAP unit
AIRFIT N20 FRAME (FOR HER)
RESMED PTY LTD
63567
In Commercial Distribution

  • 00619498635672 ()
63567

  • CPAP/BPAP nasal mask, reusable
AIRFIT N20 SML (FOR HER)
RESMED PTY LTD
63500
In Commercial Distribution

  • 00619498635009 ()
63500

  • CPAP/BPAP nasal mask, reusable
AIRFIT F20 FOR HER FRAME
RESMED PTY LTD
63466
In Commercial Distribution

  • 00619498634668 ()
63466

  • CPAP/BPAP face mask, reusable
AIRFIT F20 FOR HER MED
RESMED PTY LTD
63404
In Commercial Distribution

  • 00619498634040 ()
63404

  • CPAP/BPAP face mask, reusable
AIRFIT F20 FOR HER SML
RESMED PTY LTD
63403
In Commercial Distribution

  • 00619498634033 ()
63403

  • CPAP/BPAP face mask, reusable
AirTouch F20 for Her MED
RESMED PTY LTD
63004
In Commercial Distribution

  • 00619498630042 ()
63004

  • CPAP/BPAP face mask, reusable
AirTouch F20 for Her SML
RESMED PTY LTD
63003
In Commercial Distribution

  • 00619498630035 ()
63003

  • CPAP/BPAP face mask, reusable
QUATTRO AIR FOR HER MED-SLM
RESMED PTY LTD
62768
In Commercial Distribution

  • 00619498627684 ()
  • 00619498002368 ()
62768

  • CPAP/BPAP face mask, reusable
QUATTRO AIR FOR HER SML-SLM
RESMED PTY LTD
62767
In Commercial Distribution

  • 00619498627677 ()
  • 00619498002368 ()
62767

  • CPAP/BPAP face mask, reusable
QUATTRO AIR FOR HER XSML-SLM
RESMED PTY LTD
62766
In Commercial Distribution

  • 00619498627660 ()
  • 00619498002368 ()
62766

  • CPAP/BPAP face mask, reusable
QUATTRO FX FOR HER MED-SLM
RESMED PTY LTD
62505
In Commercial Distribution

  • 00619498625055 ()
62505

  • Rebreathing oxygen face mask
QUATTRO FX FOR HER SML-SLM
RESMED PTY LTD
62504
In Commercial Distribution

  • 00619498625048 ()
62504

  • CPAP/BPAP face mask, reusable
SWIFT FX FOR HER HEADGEAR
RESMED PTY LTD
61543
In Commercial Distribution

  • 00619498615438 ()
61543

  • CPAP/BPAP nasal mask, reusable
Let Her Dance Pool Spectacle
Kenmark Optical, Inc.
LTHDPL51
In Commercial Distribution

  • 00715317094726 ()


  • Tinted non-prescription spectacles
Let Her Dance Carbon Spectacle
Kenmark Optical, Inc.
LTHDCB51
In Commercial Distribution

  • 00715317094702 ()


  • Tinted non-prescription spectacles
Let Her Dance Antique Spectacle
Kenmark Optical, Inc.
LTHDAN51
In Commercial Distribution

  • 00715317094696 ()


  • Tinted non-prescription spectacles
Handy Grabber,1EA,6/CS
Drive Devilbiss Healthcare
RTL5023
In Commercial Distribution

  • 10822383271153 ()
  • 50822383271151 ()
  • 00822383271156 ()


  • Assistive non-gripping reach extender
Folding Suction Reacher Grabber (2PK) Version 2
VIVE HEALTH LLC
LVA2053PAK2V2
In Commercial Distribution

  • 10810113574018 ()
  • 00810113574011 ()


  • Assistive non-gripping reach extender
Folding Reacher Grabber (2PK)
VIVE HEALTH LLC
LVA2006PAK2
In Commercial Distribution

  • 10818323025399 ()
  • 00818323025392 ()


  • Assistive non-gripping reach extender
Suction Cup Reacher (2PK)
VIVE HEALTH LLC
LVA1001PAK2
In Commercial Distribution

  • 10818323024057 ()
  • 00818323024050 ()


  • Assistive non-gripping reach extender
Folding Suction Reacher Grabber (2PK)
VIVE HEALTH LLC
LVA2053PAK2
In Commercial Distribution

  • 10810041982329 ()
  • 00810041982322 ()


  • Assistive non-gripping reach extender
Folding Suction Reacher Grabber
VIVE HEALTH LLC
LVA2053
In Commercial Distribution

  • 10810041982312 ()
  • 00810041982315 ()


  • Assistive non-gripping reach extender
Folding Reacher Grabber
VIVE HEALTH LLC
LVA2006
In Commercial Distribution

  • 10810041982091 ()
  • 00810041982094 ()


  • Assistive non-gripping reach extender
Just for Her™ Period Emergency Kit for Unexpected Situations and First Time Period Emergencies
MKJ Brands Limited Liability Company
JFH00867
In Commercial Distribution

  • 10855424008678 ()
  • 00855424008671 ()
JFH00867

  • Menstrual pad, unscented
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