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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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The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size S device is designed for use on infants with a head circumference measuring 27-31cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size S
In Commercial Distribution

  • 00860008980762 ()
NEAT004-02

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size XL device is designed for use on infants with a head circumference measuring 41-48cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XL
In Commercial Distribution

  • 00860008980793 ()
NEAT004-05

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size LG device is designed for use on infants with a head circumference measuring 35-41cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size LG
In Commercial Distribution

  • 00860008980786 ()
NEAT004-04

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size M device is designed for use on infants with a head circumference measuring 31-35cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size M
In Commercial Distribution

  • 00860008980779 ()
NEAT004-03

  • Infant acoustic earmuffs
The NEATCAP® DREAMIES® device is a single use medical device designed to provide hearing protection for infants in a neonatal or pediatric intensive care unit. The Size XS device is designed for use on infants with a head circumference measuring 23-27cm. NEATCAP® DREAMIES® devices are packaged non-sterile.
NEATCAP MEDICAL LLC
Size XS
In Commercial Distribution

  • 00860008980755 ()
NEAT004-01

  • Infant acoustic earmuffs
Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae.
ADVANCED MEDICAL ASSOCIATES, LLC
57359
In Commercial Distribution

  • 00850021481148 ()
  • 00850021481124 ()
57359

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Areza Antibacterial Alginate with Silver is made of natural alginate fibers derived from seaweed through a series of special processes. Designed to be highly absorbent, the dressing rapidly absorbs exudates and forms a gel-like covering over the wound, maintaining a moist environment ideal for wound healing. The gel-like surface also keeps the dressing from adhering to the wound, so it is a painless removal. Areza Antibacterial Alginate with Silver can restrain the bacteria growing and reduce further bacterial infection. It has been tested in vitro and found to be effective against bacteria such as: Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, Escherichia coli, Pseudomonsa aeruginosa, Klebsiella pneumoniae.
ADVANCED MEDICAL ASSOCIATES, LLC
57258
In Commercial Distribution

  • 00850021481148 ()
  • 00850021481117 ()
57258

  • Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
KamDoy Rx Skin Emulsion is indicated as a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. KamDoy Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.
ALVIX LABORATORIES, LLC
FP1012-1
In Commercial Distribution

  • 00315455956612 ()


  • Skin osmotic dressing, non-sterile
AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possible complications.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411010365 ()
  • 00704411010367 ()
AS399-1

  • Wound irrigation sterile saline
AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in clinical care and should only be used by clinicians familiar with the treatment of possible complications.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 00704411007459 ()
  • 40704411007457 ()
AS399

  • Wound irrigation sterile saline
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