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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Double Nasal Hood Single Use, Adult, Scent Happy Apple 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12HA
In Commercial Distribution

  • 04260635790547 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Pediatric, Scent Bouncy Bubble 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHP12BB
In Commercial Distribution

  • 04260635790530 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Adult, Scent Bouncy Bubble 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12BB
In Commercial Distribution

  • 04260635790523 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Pediatric, Scent Strawberry Delight 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHP12SD
In Commercial Distribution

  • 04260635790486 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Pediatric, Scent Blueberry Dance 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHP12BD
In Commercial Distribution

  • 04260635790479 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Adult, Scent Strawberry Delight 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12SD
In Commercial Distribution

  • 04260635790448 ()


  • Anaesthesia face mask, single-use
Double Nasal Hood Single Use, Adult, Scent Blueberry Dance 12 Hoods individually wrapped in a box. To be used in nitrous-oxide-oxygen sedation systems for delivering to a patient a mixture of nitrous oxide and oxygen. Delivered mixed gas, nitrous oxide and oxygen, through the tubing and Inner Hood.
Baldus Sedation GmbH & Co. KG
NHA12BD
In Commercial Distribution

  • 04260635790431 ()


  • Anaesthesia face mask, single-use
The Corowell COVID-19 Symptom Screening Test is intended to objectively testing of the sense of smell. It enables the identification of subjects whose olfactory perception is deviating, restricted or newly got lost. The Corowell COVID-19 Symptom Screening Test is a device for home use. The Corowell COVID-19 Symptom Screening Test can be performed self-administered by the subject. The target population is adults over 18 years of age.
MKG Consulting UG (haftungsbeschränkt)
1
In Commercial Distribution

  • 14260698980012 ()
  • 04260698980015 ()
  • 24260698980019 ()
  • 34260698980016 ()
  • 04260698980022 ()
  • 14260698980029 ()
  • 24260698980026 ()
  • 04260698980046 ()
  • 04260698980053 ()
001

  • Olfactory test stick
The Odor Quartet is a training kit consisting of 4 olfactory pens used to improve the sense of smell. The effect of the olfactory training is based both on stimulation of the olfactory mucosa in the nose and on an improvement of sensory impressions in the brain. The Odor Quartet consists of 4 olfactory pens, which release different scents: i.e. lemon, rose, clove and eucalyptus.
Burghart Messtechnik GmbH
LA-13-00434
In Commercial Distribution

  • 04260676240209 ()
LA-13-00434

  • Olfactory test stick
The Screening 12 Test is intended to be used for examination of smell disorders on humans. The test result can be used to differentiate between Normosmia, Hyposmia, and Anosmia, if the patient is cooperative.
Burghart Messtechnik GmbH
LA-13-00437
In Commercial Distribution

  • 04260676240155 ()
LA-13-00437

  • Olfactory test stick
The Screening 12 test is intended to be used for examination of smell disorders on humans. The test results can be used to differentiate between Normosmia, Hyposmia and Anosmia, if the patient is cooperative.
Burghart Messtechnik GmbH
LA-13-00436
In Commercial Distribution

  • 04260676240148 ()
LA-13-00436

  • Olfactory test stick
Refill Kit for the Extended Test: The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.
Burghart Messtechnik GmbH
LA-13-00433
In Commercial Distribution

  • 04260676240131 ()
LA-13-00433

  • Olfactory test stick
The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.
Burghart Messtechnik GmbH
LA-13-00435
In Commercial Distribution

  • 04260676240124 ()
LA-13-00435

  • Olfactory test stick
Fertility-Friendly Water-based Personal Lubricant - Rose Scented
CC Wellness LLC
72245
In Commercial Distribution

  • 10796494003319 ()
  • 00796494003312 ()


  • Sexual lubricant
CLEANSER, APPLIANCE, URINARY, OSTOMY, DEODORANT, ACID BASED, CITRUS SCENTED, TRIAL BOTTLE 4 OZ. (188 ML.) Rinsing alone does not clean a urinary or ostomy appliance and the use of vinegar, bleaches or toilet bowl cleaners only hardens, distorts and damages rubber, latex and plastic parts—not to mention the unpleasant and embarrassing odors often created by the use of these chemicals. Urocare® recommends the use of Urolux® urinary and ostomy appliance cleanser and deodorant for cleaning latex or rubber urinary leg bags, male urinal sheaths, urinary drainage bottles, urinary drainage and extension tubing or any other reusable urinary or ostomy appliance. Urolux® is a concentrated solution specifically formulated to clean and deodorize rubber, latex or plastic urinary and ostomy appliances. Crystal build-ups are dissolved and unpleasant odors are eliminated. Don't let corrosion happen to your urinary or ostomy appliance... Use Urolux! Features: • Effectively Cleans the Entire Fluid Pathway • Fresh Citrus Scent • Concentrated Formula Goes A Long Way • Dissolves Calcium and Urine Crystal Build-Ups • For use with Urinary & Ostomy Appliances PRECAUTIONS: Urolux contains phosphoric acid which may cause burns to skin and eyes. Avoid contact with all materials other than glass, plastics, rubber and latex. Avoid contamination of food and contact with skin and eyes. Use only as directed. Keep out of reach of children.
UROCARE PRODUCTS, INC.
700204
In Commercial Distribution

  • 10792293702040 ()
  • 00792293702043 ()

  • Total Volume: 118 Milliliter
  • Total Volume: 4 Fluid Ounce
  • Trial Bottle
  • Outer Diameter: 1.75 Inch
  • Height: 5.25 Inch
  • Weight: 0.34 Pound
700204

  • Penis/scrotum wearable urinal
  • Non-wearable adult urine collection bag, open-ended
  • Open-ended wearable urine collection bag, non-sterile
  • Hand-held urinal, reusable
  • Urinary incontinence penis sheath/port, single-use
Fertility-Friendly Water-based Personal Lubricant - Rose Scented
CC Wellness LLC
72237
In Commercial Distribution

  • 10796494002947 ()
  • 00796494002940 ()


  • Sexual lubricant
Fertility-Friendly Water-based Personal Lubricant - Rose Scented
CC Wellness LLC
72236
In Commercial Distribution

  • 10796494002930 ()
  • 00796494002933 ()


  • Sexual lubricant
Water-Based Lubricant
CC Wellness LLC
40133
In Commercial Distribution

  • 10796494001803 ()
  • 00796494001806 ()


  • Sexual lubricant
ADHESIVE REMOVER, PADS, WIPES, SACHETTE, SILICONE, URINE COLLECTION, OSTOMY, MALE EXTERNAL CATHETER, LATEX-FREE, NON-FLAMMABLE Urocare® adhesive remover has been specifically formulated for dissolving and removing unwanted adhesive or adhesive residue from urinary and ostomy appliances, tens units, monitoring electrodes, skin and can even be used for the removal of tar. Packaged in a small, convenient wipe, Urocare® adhesive remover pads are the perfect solution to aid in the removal of adhesive residue left behind by male external catheters. They may be used to soften the adhesive of double-sided adhesive foam strips as well as most brush-on medical adhesives. They contain a lab tested, non-toxic, citrus-based solution that may also be used to remove these types of medical adhesives or adhesive residue from skin and appliances in preparation for the use of a new adhesive strip/wafer. It is recommended that a male external catheter be changed once a day to promote healthy skin. With the use of Urocare® adhesive remover pads, a male external catheter can be changed quickly and easily. Key Features: • NON-TOXIC—Lab Tested, non-toxic and free from harsh solvents. • Citrus-Based—Fresh citrus scent and biodegradable. • Many Uses—Use on nitro patches, tens units, electrodes, even tar. • Convenient—Travel size pads are small and easy to use • Soap & Water Clean-Up—Just wash, rinse and dry • Suitable for Hospital, Long-Term Care and Home Use • Alcohol-Free Formula • Environmentally Friendly—Does not contain ozone-depleting chloro-fluorocarbons • Convenient Packaging—Use only what you need so there's less waste Note: For external use only.
UROCARE PRODUCTS, INC.
5600
In Commercial Distribution

  • 00792293056009 ()

  • Width: 2.25 Inch
  • Depth: 0.1 Inch
  • Height: 2.25 Inch
  • Weight: 0.004 Pound
5600

  • Patient medical adhesive remover
  • Skin surface device adhesive
  • Urinary incontinence penis sheath/port, single-use
Blue Diamond® Gel pad that is 5" x 7" x 3/8" thick and used for a variety of pressure management scenarios.
David Scott Company
BD0100-5738
In Commercial Distribution

  • 15060797551088 ()

  • Width: 5 Inch
  • Length: 7 Inch
  • Height: .375 Inch
BD0100-5738

  • Operating table patient pressure distribution pad, reusable
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