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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No Description
OKB RITM, ZAO
CHANS-01-SCENAR-M
In Commercial Distribution

  • 04650057290051 ()


  • Analgesic transcutaneous electrical nerve stimulation system
Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.
R.G. ENTERPRISES (U.S.A.), INC.
Super Mini-Rescue II Unique Resc+ R-150
In Commercial Distribution

  • 00614801001502 ()

  • Length: 19 Inch
  • Height: 19 Inch
80613

  • Rescue blanket, reusable
Thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached. Operates using battery or medical grade power supply.
R.G. ENTERPRISES (U.S.A.), INC.
Mini-Rescue II UniqueResc R130
In Commercial Distribution

  • 00614801001304 ()

  • Length: 33 Inch
  • Height: 19 Inch
80612

  • Rescue blanket, reusable
Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Brentronics Battery Assembly
In Commercial Distribution

  • 00614801000055 ()
82015

  • Portable/mobile rechargeable battery pack
Battery for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Ultralife Battery Assembly
In Commercial Distribution

  • 00614801000048 ()
82039

  • Portable/mobile rechargeable battery pack
Auxiliary Vehicle Cable for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Aux Vehicle Cable
In Commercial Distribution

  • 00614801000031 ()
82019

  • Electrical mains power extension cable
Battery Adapter Cable for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Battery Adapter Cable
In Commercial Distribution

  • 00614801000024 ()
82024

  • Electrical mains power extension cable
Power Supply Unit for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Power Supply Unit
In Commercial Distribution

  • 00614801000017 ()
82009

  • Basic power supply, reusable
Charger assembly for thermal regulating systems to prevent/treat hypothermia in pre clinical settings or treatment on site. Intended for use at rescue scene, during patient transport by air or ground to medical facility. Selectable temperature ranging from 98.6F to 104F via control unit with visual and acoustic alarm systems to indicate when temperature is reached.
R.G. ENTERPRISES (U.S.A.), INC.
Charger Assembly Lithium Ion Battery
In Commercial Distribution

  • 00614801000000 ()
82025

  • Noninvasive device battery charger
No Description
FLEXICARE MEDICAL LIMITED
035-55-210GU
In Commercial Distribution

  • 05055788753926 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-210SU
In Commercial Distribution

  • 05055788753902 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-220SU
In Commercial Distribution

  • 05055788753865 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-220VU
In Commercial Distribution

  • 05055788753834 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-230MU
In Commercial Distribution

  • 05055788753803 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
035-55-230VU
In Commercial Distribution

  • 05055788753773 ()


  • Anaesthesia face mask, single-use
Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the LITTLEmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000042
In Commercial Distribution

  • 00850011150078 ()
10000042

  • Assistive speech generator
Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario. Includes ableCARE on-demand support Built ableSTRONG to endure drops and other environmental conditions Made from ableSAFE materials and tested by third-party safety labs Common Uses Request like "I want" or "I need help" Participate in an activity with "turn the page" or "It's your turn" Tell your classmates what you did over the weekend during a morning meeting Add communication to a switch controlled toy or applianceg Features Better than ever digital sound output suitable for almost any environment Includes red, yellow, green, and blue colored tops Clear snap cover to attach picture symbols and provide communication context to the user Soft-touch coating makes the device easier to hold Symbol Overlays Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000041
In Commercial Distribution

  • 00850011150061 ()
10000041

  • Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay
No Description
FLEXICARE MEDICAL LIMITED
038-51-400SFLU
In Commercial Distribution

  • 05055788740155 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-51-410SFLU
In Commercial Distribution

  • 05055788739807 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-52-415SFLU
In Commercial Distribution

  • 05055788739494 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-52-415SFSU
In Commercial Distribution

  • 05055788739388 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-52-420SFLU
In Commercial Distribution

  • 05055788739173 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-52-420SFSU
In Commercial Distribution

  • 05055788739067 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-52-430SFLU
In Commercial Distribution

  • 05055788738879 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-52-430SFSU
In Commercial Distribution

  • 05055788738763 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-53-440SFLU
In Commercial Distribution

  • 05055788738572 ()


  • Anaesthesia face mask, single-use
No Description
FLEXICARE MEDICAL LIMITED
038-53-440SFSU
In Commercial Distribution

  • 05055788738473 ()


  • Anaesthesia face mask, single-use
The Defender Room Air Cleaner ("Defender") is a portable, mechanical air filtration system designed for single use int he home environment. It is configured as a circular unit with a protective outer housing, a pleated fiberglass filter that exceeds HEPA filters in both efficiency and particulate size, and an oxygen activated charcoal filter (HEGA) to remove gasses and odors. During operation, air is drawn into the lower assembly, passes through the upper assembly providing a 360-degree flow of air. The unit is equipped with a scent generator powered by a small heating element. Outlet filtered air passes through the scent generator and out from the top of the unit. The Defender is intended to filter indoor air to remove micro-particles as small as 0.1 micron in size. Including dust, pollen, smoke, dust mites allergens, cockroach allergens, bacteria, mold and pet allergens. The Defender is also intended to remove Tobacco smoke and other household odors.
Health Mor At Home Cbp
D11NA
In Commercial Distribution

  • 00863342000318 ()


  • High-efficiency filter air cleaner, mobile
Mouthpiece, TruFit, Soft Flange, Blue, Vanilla Scent, Disposable
Medi/Nuclear Corporation, Inc.
MN2550B
In Commercial Distribution

  • 00857863007895 ()
  • 00857863007857 ()


  • Breathing mouthpiece, single-use
SCEW GUIDE
MEDTRONIC SOFAMOR DANEK, INC.
X0300019
In Commercial Distribution

  • 00673978995656 ()


  • General internal orthopaedic fixation system implantation kit
ULTRA THIN FOAM REGULAR PAD w/ WINGS SCENTED 30 CT
MEIJER, INC.
4703023
In Commercial Distribution

  • 10719283754902 ()
  • 00719283754905 ()
  • 00071928375495 ()


  • Menstrual pad, scented
MULTI PACK SCENTED PLASTIC APPLICATOR TAMPONS
MEIJER, INC.
ME13612SA
In Commercial Distribution

  • 00719283200112 ()
  • 00071928320011 ()
  • 10719283200119 ()


  • Menstrual tampon, scented
MULTI PACK SCENTED PLASTIC APPLICATOR TAMPONS
MEIJER, INC.
ME63606SA
In Commercial Distribution

  • 00719283200075 ()
  • 00071928320007 ()
  • 10719283200072 ()


  • Menstrual tampon, scented
No Description
KMART HOLDING CORPORATION
BKMSGP36
In Commercial Distribution

  • 10883967418364 ()
  • 00883967418367 ()
  • 07290016625172 ()

  • Absorbency


  • Menstrual tampon, scented
No Description
KMART HOLDING CORPORATION
BKMSGS18
In Commercial Distribution

  • 10883967382252 ()
  • 00883967382255 ()
  • 07290016625165 ()

  • Absorbency


  • Menstrual tampon, scented
No Description
KMART HOLDING CORPORATION
BKMSGR18
In Commercial Distribution

  • 10883967382245 ()
  • 00883967382248 ()
  • 07290016625158 ()

  • Absorbency


  • Menstrual tampon, scented
Every Cycle reusable tampon applicator
Cycle LLC
7000
In Commercial Distribution

  • 00860007113727 ()


  • Menstrual tampon, unscented
  • Menstrual tampon, scented
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431591
In Commercial Distribution

  • 04056869975559 ()


  • PET system application software
  • SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431562
In Commercial Distribution

  • 04056869950198 ()


  • SPECT system application software
  • PET system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11431532
In Commercial Distribution

  • 04056869243405 ()


  • PET system application software
  • SPECT system application software
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