SEARCH RESULTS FOR: hibcc(8892 results)
SUPARTZ (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from rooster combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-5555-01
Not in Commercial Distribution
- M717715655554 ()
- M717715655553 ()
- M717715655552 ()
- M717715655550 ()
7156-5555
- Synovial fluid supplementation medium
SUPARTZ FX (P980044) is indicated for treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen. SUPARTZ FX is a sterile, viscoelastic, non-pyrogenic solution (pH of 6.8-7.8) of highly purified, high molecular weight hyaluronic acid (HA) (620 000-1 170 000 daltons). HA, which is extracted from chicken combs, is a polysaccharide containing repeating disaccharide units of glucuronic acid and N-acetylglucosamine. HA is a common constituent of the extracellular matrix of connective tissues. SUPARTZ FX is supplied sterile in single-use, pre-filled, disposable plastic syringes, each containing 25 mg of HA dissolved in a Phosphate Buffered Saline (PBS) solution (2.5 mL of 1.0% solution).
SEIKAGAKU CORPORATION
89130-4444-1
In Commercial Distribution
- M717715644440 ()
- M717715644442 ()
- M717715644443 ()
- M717715644444 ()
7156-4444
- Synovial fluid supplementation medium
The VASCADE MVP Venous Vascular Closure System (VVCS) 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 6Fr 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.
800-612C
In Commercial Distribution
- M729800612C2 ()
- M729800612C0 ()
- M729800612C1 ()
- M729800612C3 ()
- Catheter Gauge: 6 to 12 French
- Femoral artery closure plug/patch, collagen
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
The ResQCPR system contains two ResQPODs and one ResQPump
ADVANCED CIRCULATORY SYSTEMS INC
12-0825-000
In Commercial Distribution
- M5921208220000 ()
- M5921208250001 ()
- M5921208230001 ()
- Cardiac resuscitator, manual
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 6F & 7F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-580I
In Commercial Distribution
- M729700580I1 ()
- M729700580I0 ()
- M729700580I3 ()
- Catheter Gauge: 7 French
- Catheter Gauge: 6 French
- Femoral artery closure plug/patch, collagen
The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
CARDIVA MEDICAL, INC.
700-500DX
In Commercial Distribution
- M729700500DX1 ()
- M729700500DX0 ()
- M729700500DX3 ()
- Catheter Gauge: 5 French
- Femoral artery closure plug/patch, collagen
The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).
Beyond Air, Inc.
90015
In Commercial Distribution
- B882900151 ()
- B882900150 ()
- B882900152 ()
- Nitric oxide delivery system, secondary
The Nitric Oxide Delivery Module (NDM) measures gas flow in the ventilator breathing circuit (flow sensor) and delivers nitric oxide gas mixture into the inspiratory limb of the ventilator breathing circuit (injector line and adapter). The NDM is placed close to the ventilator gas outlet (at least 6 inches/15 cm from the ventilator inspiratory outlet and before the humidifier) to allow for proper mixing of nitric oxide enriched gas from the NDM with the ventilator delivered gas flow. NDM Assembly, comprised of NO Injector Adapter and Tubing, Flow Sensor. Flow enters the flow sensor and exits through the injector adapter. The disposable, single use NDM flow sensor provides a bidirectional, high speed/high accuracy, real time measurement of gas flow in the ventilator breathing circuit, allowing for proper calculation of the required nitric oxide flow output needed to maintain the set NO concentration. NDM kit components, except for the NDM Cable, to be used on one patient only.
Beyond Air, Inc.
90014
In Commercial Distribution
- B882900141 ()
- B882900140 ()
- B882900142 ()
- Nitric oxide delivery system, secondary
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 system, secondary