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Lumin serves as both a general-purpose sanitizing device for personal care items (e.g. cell phone, eyeglasses, keys, etc.) as well as CPAP accessories (e.g. hose, mask, and water chamber. In terms of CPAP sanitizer, there is no requirement for sterility or disinfection for single-patient re-use of CPAP accessories in the home. Most manufacturer instructions require simple cleaning with soap and water. Lumin is intended to be used as an adjunct to following the manufacturer’s instructions for routine cleaning but provides the convenience of bioburden reduction in 5 minutes. Lumin is designed to be used only with the CPAP accessories (i.e. CPAP Mask, hose, and water chamber), and not on the CPAP machine itself.
3B MEDICAL, INC.
LM3000
In Commercial Distribution
- 00860006339906 ()
- Ultraviolet device disinfection chamber
proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function. This device can be used at office and required to be used in a quiet environment. This device targets patients over 18 years of age.
Soundable Health, Inc.
SU-UFM-001
In Commercial Distribution
- 00860006184926 ()
- Home uroflowmetry software
proudP is a mobile application intended for measuring voided volume of urine and urine flow rate using the sound recorded by microphone in mobile devices. This device can be used for assessment of voiding function.
This device can be used at home and required to be used in a quiet environment.
This device targets patients over 18 years of age.
Soundable Health, Inc.
SU-UFM-001
In Commercial Distribution
- 00860006184902 ()
- Home uroflowmetry software
No Description
Tmr Orthopedics, LLC
TMR 001-6.5-120
In Commercial Distribution
- 00860006173302 ()
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).
Mahana Therapeutics, Inc.
01-0001-001
In Commercial Distribution
- 00860006172008 ()
01-0001-001
- Mindfulness/behavioural therapy software, non-clinician-consultative
Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution
- 00860006137014 ()
- Medical networking interface unit
eClinics is a stand-alone software product used by professional care providers in ICU and other critical care settings for the presentation, collection, management and storage of patient information
Ceiba Healthcare Technologies LLC
eClinics
In Commercial Distribution
- 00860006137007 ()
- Medical equipment clinical data interfacing software
SILICONE Personal Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Premium Natural Cosmetics Inc.
00860006114107
In Commercial Distribution
- 00860006114107 ()
- Sexual lubricant
Silicone Male External Catheter. Self-Adhering. Non-Sterile.
Flex Source International, Inc.
Size 32MM - # 7732-30
In Commercial Distribution
- 00860006105099 ()
- 00860006105075 ()
- Urinary incontinence penis sheath/port, single-use
Silicone Male External Catheter. Self-Adhering. Non-Sterile.
Flex Source International, Inc.
Size 29MM - # 7729-30
In Commercial Distribution
- 00860006105051 ()
- 00860006105037 ()
- Urinary incontinence penis sheath/port, single-use