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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Every Cycle reusable tampon applicator
Cycle LLC
7000
In Commercial Distribution

  • 00860007113727 ()


  • Menstrual tampon, unscented
  • Menstrual tampon, scented
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
AquariusWeb Viewer (aka AqWeb or Web Viewer, marketing term) is a version of iNtuitionEMV with a focus on 3D rendering, additionally providing workflow and scene support.
Terarecon Inc.
Aquarius Web
In Commercial Distribution

  • INTUITION6 ()


  • Radiological PACS software
Intuition Web (aka AquariusWeb Viewer and AqWeb or Web Viewer, marketing term) is a version of Intuition EMV (aka iNtuitionEMV) with a focus on 3D rendering, additionally providing workflow and scene support.
Terarecon Inc.
Intuition Web
In Commercial Distribution

  • INTUITION11 ()


  • Radiological PACS software
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
Bubble gum scented disposable anesthesia face mask
Ambu A/S
K1122
In Commercial Distribution

  • 00612649182865 ()
  • 00612649204154 ()
  • 05707480132355 ()

  • 2
  • Size 1
K1122

  • Anaesthesia face mask, single-use
MESH 9352515 25MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352515
Not in Commercial Distribution

  • 00613994218872 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352504 25MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352504
Not in Commercial Distribution

  • 00613994218858 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352500 25MM ENDCAP 0 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352500
In Commercial Distribution

  • 00613994218841 ()

  • 25mm


  • Polymeric spinal interbody fusion cage
MESH 9352215 22MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352215
Not in Commercial Distribution

  • 00613994218834 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352208 22MM ENDCAP 8 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352208
Not in Commercial Distribution

  • 00613994218827 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352204 22MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352204
In Commercial Distribution

  • 00613994218810 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9352200 22MM ENDCAP 0 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9352200
In Commercial Distribution

  • 00613994218803 ()

  • 22mm


  • Polymeric spinal interbody fusion cage
MESH 9351915 19MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351915
Not in Commercial Distribution

  • 00613994218797 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
MESH 9351908 19MM ENDCAP 8 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351908
Not in Commercial Distribution

  • 00613994218780 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
MESH 9351904 19MM ENDCAP 4 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
9351904
Not in Commercial Distribution

  • 00613994218773 ()

  • 19mm


  • Polymeric spinal interbody fusion cage
Scented disposable anesthesia face mask - variety pack
Ambu A/S
1443
In Commercial Distribution

  • 00612649101613 ()
  • 00612649185217 ()

  • 4
  • Size 2
1443

  • Anaesthesia face mask, single-use
Scented disposable anesthesia face mask - variety pack
Ambu A/S
1433
In Commercial Distribution

  • 00612649101590 ()
  • 00612649185200 ()

  • Size 2
  • 3
1433

  • Anaesthesia face mask, single-use
Cherry scented disposable anesthesia face mask
Ambu A/S
1345
In Commercial Distribution

  • 00612649101552 ()
  • 00612649185163 ()

  • 4
  • Size 2
1345

  • Anaesthesia face mask, single-use
Cherry scented disposable anesthesia face mask
Ambu A/S
1332
In Commercial Distribution

  • 00612649101514 ()
  • 00612649185125 ()
  • 05707480132409 ()

  • Size 2
  • 3
1332

  • Anaesthesia face mask, single-use
Strawberry scented disposable anesthesia face mask
Ambu A/S
1245
In Commercial Distribution

  • 00612649101453 ()
  • 00612649185088 ()

  • Size 2
  • 4
1245

  • Anaesthesia face mask, single-use
Strawberry scented disposable anesthesia face mask
Ambu A/S
1232
In Commercial Distribution

  • 05707480132386 ()
  • 00612649101415 ()
  • 00612649185057 ()

  • 3
  • Size 2
1232

  • Anaesthesia face mask, single-use
Strawberry scented disposable anesthesia face mask
Ambu A/S
1222
In Commercial Distribution

  • 05707480132379 ()
  • 00612649101392 ()
  • 00612649185033 ()

  • Size 1
  • 2
1222

  • Anaesthesia face mask, single-use
Bubble gum scented disposable anesthesia face mask
Ambu A/S
1132
In Commercial Distribution

  • 00612649101323 ()
  • 00612649184975 ()
  • 05707480132362 ()

  • Size 2
  • 3
1132

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2075
In Commercial Distribution

  • 00612649102238 ()
  • 00612649185552 ()

  • Size 2
  • 7
2075

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2065
In Commercial Distribution

  • 00612649102160 ()
  • 00612649185491 ()

  • 6
  • Size 2
2065

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2055
In Commercial Distribution

  • 00612649102146 ()
  • 00612649185460 ()

  • 5
  • Size 2
2055

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2045
In Commercial Distribution

  • 00612649102115 ()
  • 00612649185439 ()

  • 4
  • Size 2
2045

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2032
In Commercial Distribution

  • 00612649102078 ()
  • 00612649185385 ()
  • 05707480132348 ()

  • Size 2
  • 3
2032

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2022
In Commercial Distribution

  • 00612649102023 ()
  • 00612649185361 ()
  • 05707480132331 ()

  • 2
  • Size 1
2022

  • Anaesthesia face mask, single-use
Fresh scented disposable anesthesia face mask
Ambu A/S
2012
In Commercial Distribution

  • 00612649101965 ()
  • 00612649185323 ()
  • 05707480132324 ()

  • Size 1
  • 1
2012

  • Anaesthesia face mask, single-use
Scented disposable anesthesia face mask - variety pack
Ambu A/S
1423
In Commercial Distribution

  • 00612649101576 ()
  • 00612649185187 ()

  • 2
  • Size 1
1423

  • Anaesthesia face mask, single-use
Cherry scented disposable anesthesia face mask
Ambu A/S
1322
In Commercial Distribution

  • 00612649101491 ()
  • 00612649185101 ()
  • 05707480132393 ()

  • 2
  • Size 1
1322

  • Anaesthesia face mask, single-use
Bubble gum scented disposable anesthesia face mask
Ambu A/S
1145
In Commercial Distribution

  • 00612649101378 ()
  • 00612649185019 ()

  • Size 2
  • 4
1145

  • Anaesthesia face mask, single-use
No Description
HITACHI, LTD.
SCENARIA View
Not in Commercial Distribution

  • 04580292766694 ()


  • Full-body CT system
No Description
HITACHI, LTD.
Scenaria
Not in Commercial Distribution

  • 04580292766441 ()


  • Full-body CT system
Full-body CT system
FUJIFILM CORPORATION
SCENARIA View
In Commercial Distribution

SCENARIA View

  • Full-body CT system
SCENTED, VANILLA, ANAESTHETIC FACE MASK, SIZE 5, LARGE ADULT, 22F
Intersurgical Incorporated
1125000
In Commercial Distribution

  • 05030267036516 ()
  • 05030267050994 ()


  • Anaesthesia face mask, single-use
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02.1)
In Commercial Distribution

  • 04650057290631 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02)
In Commercial Distribution

  • 04650057290082 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
CHANS-01-SCENAR-M
In Commercial Distribution

  • 04650057290051 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02C)
In Commercial Distribution

  • 04650057290679 ()


  • Analgesic transcutaneous electrical nerve stimulation system
No Description
OKB RITM, ZAO
SCENAR-1-NT (version 02.1C)
In Commercial Distribution

  • 04650057290662 ()


  • Analgesic transcutaneous electrical nerve stimulation system
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