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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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ManaCold Platinum Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following knee surgery, shoulder surgery or back surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
Manamed, Inc.
ManaCold Platinum Univeral Combo Unit
In Commercial Distribution

  • 00810113682594 ()
MANACOLD01-PT

  • Circulating-fluid localized thermal therapy system
  • Circulating-fluid localized thermal therapy system pack, reusable
ManaCold Platinum Water Circulating Therapy Device is used decrease pain, swelling, and muscle spasms after surgery or injury. ManaCold consists of a cold water circulating unit, a 9 quart cooling reservoir with a lid, 7 foot insulation tube and a cold therapy pad. The cold therapy pad is applied to a patients injured area, delivering cold therapy through the tubing and into the cold pad. Commonly used following shoulder surgery ManaCold can be used and operated by a patient or healthcare provider in a home or clinical setting
Manamed, Inc.
ManaCold Platinum Shoulder Combo Unit
In Commercial Distribution

  • 00810113682563 ()
MANACOLD-PTSHLD

  • Circulating-fluid localized thermal therapy system
  • Circulating-fluid localized thermal therapy system pack, reusable
HAMILTON-BC4022, breathing circuit set, single limb, heated, with water chamber
Hamilton Medical AG
260186
In Commercial Distribution

  • 07630002804189 ()
  • 17630002804186 ()
260186

  • Ventilator breathing circuit, single-use
  • Inspiratory line humidification chamber, single-use
HAMILTON-BC8022, breathing circuit set, dual limb, heated, with water chamber
Hamilton Medical AG
260161
In Commercial Distribution

  • 07630002801560 ()
  • 17630002801567 ()
260161

  • Ventilator breathing circuit, single-use
  • Inspiratory line humidification chamber, single-use
HAMILTON-BC8010, breathing circuit set, dual limb, heated, with water chamber
Hamilton Medical AG
260185
In Commercial Distribution

  • 07630002800846 ()
  • 17630002800843 ()
260185

  • Ventilator breathing circuit, single-use
  • Inspiratory line humidification chamber, single-use
Custom PHI Vent - Adult Kit
BOUND TREE MEDICAL, LLC
8600-01126
In Commercial Distribution

  • 00815277022309 ()
  • 00810094572112 ()
8600-01126

  • Ventilator breathing circuit, single-use
  • Heat/moisture exchanger, single-use
HAMILTON-BC4010, breathing circuit set, single limb, heated, with water chamber
Hamilton Medical AG
260187
In Commercial Distribution

  • 07630002801416 ()
  • 17630002801413 ()
260187

  • Ventilator breathing circuit, single-use
  • Inspiratory line humidification chamber, single-use
RESmartĀ® BPAP System with Integrated Heated Humidifier
BMC Medical Co., Ltd.
25A (BMC-50)
In Commercial Distribution

  • 06948538365144 ()


  • Heated respiratory humidifier
  • Home BPAP unit
Mains powered, infrared phototherapy and nail laser phototherapy device emitting up to 25 W at 980/810nm in CW or pulsed modes with a 10" touch screen display.
LITECURE LLC
LTS-2500
In Commercial Distribution

  • 00854103007059 ()


  • Musculoskeletal/physical therapy laser, professional
  • Nail laser phototherapy unit
Mains powered, infrared and nail laser phototherapy device emitting up to 15 W at 810 & 980 nm and up to 25 W at 980 nm. At 810 & 980 nm, the LightForce EXP (LTS-1500P) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. At 980 nm, the EXP is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g. dermatophytes, Trichophyton rubrum and Tmentagrophytes, and/or yeasts Candida albicans, etc.). The EXP is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTS-1500P
In Commercial Distribution

  • 00854103007035 ()


  • Nail laser phototherapy unit
  • Musculoskeletal infrared phototherapy unit, non-wearable
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