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The intended use for the ML6710i laser is photoactivation of VISUDYNE® (verteporfin for injection), which is a light-activated drug used in photodynamic therapy (PDT) for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis.
Please consult the VISUDYNE® (Bausch & Lomb Incorporated) prescribing information for additional information on intended use, recommended drug and light dose, administration instructions, contraindications, warnings and precautions, and side effects of VISUDYNE® treatment.
Modulight Oyj
ML6710i
In Commercial Distribution
- 06429810677020 ()
- Ophthalmic diode laser system
There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009).
The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below.
The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers.
The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).
Beyond Air, Inc.
90008
In Commercial Distribution
- B882900081 ()
- B882900080 ()
- B882900082 ()
- Nitric oxide delivery unit, system-based
Indications for FH:
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The SULFLUX KP-05 Plasma Separator is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
KP-05
In Commercial Distribution
- 14537693900636 ()
- 04537693900639 ()
- Apheresis system filter, whole blood
Indications for FH:
The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(UL)
In Commercial Distribution
- 18855036020688 ()
- 28855036020685 ()
- Apheresis system tubing set
Indications for FH:
The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in performing low density lipoprotein cholesterol (LDL-C) apheresis to acutely remove LDL-C from the plasma.
Indications for FSGS:
The Tubing System for Plasmapheresis NK-M3R(U) is one of three disposable device components of the LIPOSORBER® LA-15 System. The LIPOSORBER® LA-15 System is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis (FSGS).
KANEKA PHARMA AMERICA LLC
NK-M3R(U)
In Commercial Distribution
- 18855036012850 ()
- 28855036012857 ()
- Apheresis system tubing set
The EXOGEN device provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. The EXOGEN Ultrasound Bone Healing Systems has been designed both for use with conservatively treated fresh fractures and non-unions or surgically treated non-unions. The device transmits a low intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. The low-intensity pulsed ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing. The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. The device automatically alerts the patient in case of improper application or device performance. The EXOGEN Ultrasound Bone Healing System consists of one main operating unit, gel bottles and strap. The main operating unit provides the treatment control circuitry, the primary battery supply, and monitors the operation of the transducer at the fracture site. The signal specifications cannot be changed.
BIOVENTUS LLC
71034600
In Commercial Distribution
- M937710346001 ()
71034600
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
There are two NO2 filters in the LungFit PH; the main 12 hr NO2 filter (p/n 90008) that the user can change and the internal bagging 48 hr NO2 filter p/n 90009).
The purpose of the NO2 filters is to remove NO2 from the NO gas flow and to collect any particulates that may be in the gas flow path. When the main 12 hr filter is inserted, this NO2 filter communicates with the LungFit device through an RFID wireless chip that is mounted on the filter. The RFID chip on the filter tracks and updates with the filter’s remaining usage time to prevent the filter from being accidently re-used after it has been consumed. The RFID also communicates wirelessly with the Gas Monitoring CPU, as described below.
The NO2 filter includes two 1µm filters and two 5µm filters, with the NO2 filter material Sofnolime (soda lime) sandwiched between the particulate filters. Soda lime is a material that is commonly used in anesthesia CO2 absorbers.
The duration of use for each main filter is pre-established as 12 hours. The RFID tag tracks filter usage so that the remaining time is updated continually every minute and displayed on the device user interface (i.e., as Time Remaining). The Gas Monitoring CPU detects whether a filter is installed and displays the Change Filter alarm to alert the user to change/insert a new user when no NO2 filter is present. The device also displays the Change Filter alarm when the NO2 filter has been consumed (no more minutes remaining).
The internal Bagging NO2 filter is the same basic design as the main NO2 filter that is inserted on the front of the device. The bagging NO2 filter’s useful life is 48 hours because the concentration of NO delivered through this filter is always 20 ppm at 10 L/min whereas up to 80ppm NO can be delivered through the main NO2 filter (or four times more than the backup system). The filter time remaining is tracked in the backup delivery microprocessors nonvolatile memory instead of on a RFID tag like the main NO2 Filter.
Beyond Air, Inc.
90009
In Commercial Distribution
- B882900091 ()
- B882900090 ()
- B882900092 ()
- Nitric oxide delivery unit, system-based
Radiesse Injectable Implant is a volumizing filler indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. Radiesse Volumizing Filler Kit contains (1) injectable implant and (2) 27 gauge thin walled x 0.75 inch needles. RADIESSE injectable implant is also indicated for hand augmentation to correct volume loss in the dorsum of the hands.
MERZ NORTH AMERICA, INC.
8071C0K1
In Commercial Distribution
- M2138071C0K15 ()
- Total Volume: 1.5 Milliliter
- Dermal tissue reconstructive material, synthetic mineral
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3365-40Q
In Commercial Distribution
- 05414734508292 ()
CD3365-40Q
- Cardiac resynchronization therapy implantable defibrillator
Cardiac resynchronization device, tiered-therapy cardioverter/defibrillator VVED DDDRV
ST. JUDE MEDICAL, INC.
CD3357-40Q
In Commercial Distribution
- 05414734508216 ()
- Total Volume: 36 Milliliter
CD3357-40Q
- Cardiac resynchronization therapy implantable defibrillator