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HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking.The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals.
FIDIA FARMACEUTICI SPA
89122-0496-63
Not in Commercial Distribution
- M71389122049663A16 ()
- M71389122049663 ()
- Total Volume: 3 Milliliter
89122-0496-63
- Synovial fluid supplementation medium
The VASCADE MVP XL Venous Vascular Closure System (VVCS) 10-12F is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 10Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
800-1012XL
In Commercial Distribution
- M7298001012XL2 ()
- M7298001012XL0 ()
- M7298001012XL1 ()
- M7298001012XL3 ()
- Catheter Gauge: 10 to 12 French
- Femoral artery closure plug/patch, collagen
Blood Glucose Test Strips - 35 Test Strips (one 25 count bottle (Primary DI Number 10301937310253) and one 10 count bottle (Primary DI Number 10301937313100)).
ASCENSIA DIABETES CARE US INC.
7283
Not in Commercial Distribution
- 40301937283350 ()
- 00301937283352 ()
- 0193-7283-35 ()
- 00301937283017 ()
84698032
- Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 10 Test Strips.
ASCENSIA DIABETES CARE US INC.
7313
In Commercial Distribution
- 10301937313100 ()
- 40301937313101 ()
- 00301937313103 ()
- 0193-7313-10 ()
- 00301937313011 ()
83624796
- Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7311
In Commercial Distribution
- 40301939736502 ()
- 00301937311505 ()
- 10301937311502 ()
- 40301937311503 ()
- 0193-7311-50 ()
- 00301937311017 ()
- 40301935540042 ()
83624710
- Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 25 Test Strips.
ASCENSIA DIABETES CARE US INC.
7310
In Commercial Distribution
- 40301939735253 ()
- 00301937310256 ()
- 10301937310253 ()
- 40301937310254 ()
- 0193-7310-25 ()
- 00301937310010 ()
83623099
- Glucose monitoring system IVD, home-use
Blood Glucose Test Strips - 50 Test Strips.
ASCENSIA DIABETES CARE US INC.
7308
Not in Commercial Distribution
- 40301937308503 ()
- 00301937308505 ()
- 10301937308502 ()
- 0193-7308-50 ()
- 00301937308017 ()
83623064
- Glucose monitoring system IVD, home-use
Blood Glucose Test strips. 35 test strips.
ASCENSIA DIABETES CARE US INC.
7277
In Commercial Distribution
- 40301937277359 ()
- 00301937277351 ()
- 10301937277358 ()
- 00301937277016 ()
85723154
- Glucose monitoring system IVD, home-use
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