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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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Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and tubing, fluid cartridge, and power supply that cools the forehead while the patient sleeps.
CEREVE INC
EOS-30000-007
In Commercial Distribution

  • 00864302000300 ()


  • Circulating-fluid localized thermal therapy system
Refurbished Brace Direct Cryotherapy Machine – Advanced Cold Therapy for Faster Recovery Experience the power of cold therapy with our refurbished Brace Direct Cryotherapy Machine. Expertly restored for peak performance, it helps relieve post-surgical pain, arthritis, muscle spasms, and sports injuries. Compact, quiet, and easy to use—your go-to for faster recovery and lasting relief.
BRACE ALIGN LLC
UCTY194-2
In Commercial Distribution

  • 00860011821847 ()


  • Circulating-fluid localized thermal therapy system
Water circulating hot or cold pack.
Ermi LLC
THR
In Commercial Distribution

  • 00860011691501 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Pro Umbilical
HYPOTHERMIA DEVICES, INC.
KLV40001
In Commercial Distribution

  • 00850001185011 ()


  • Circulating-fluid localized thermal therapy system
Kelvi Pro Console
HYPOTHERMIA DEVICES, INC.
KLV10001
In Commercial Distribution

  • 00850001185004 ()


  • Circulating-fluid localized thermal therapy system
HUMIDAIR CLEANABLE - UDI
RESMED PTY LTD
37479
In Commercial Distribution

  • 00619498004720 ()
  • 00619498374793 ()
37479

  • Heated respiratory humidifier
HUMIDAIR STANDARD TUB
RESMED PTY LTD
37299
In Commercial Distribution

  • 00619498372997 ()
37299

  • Heated respiratory humidifier
H5i
RESMED PTY LTD
36901
In Commercial Distribution

  • 00619498369010 ()


  • Heated respiratory humidifier
H5i OUTLET CLIP & FITTING
RESMED PTY LTD
36894
In Commercial Distribution

  • 00619498368945 ()
36894

  • Heated respiratory humidifier
H5i TUB SEAL
RESMED PTY LTD
36892
In Commercial Distribution

  • 00619498368921 ()
36892

  • Heated respiratory humidifier
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