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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
LOADING SYS LS-ENVEOR-34-US COMM
MEDTRONIC COREVALVE LLC
LS-ENVEOR-34-US
In Commercial Distribution
- 00643169640344 ()
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
DELIV SYS ENVEOR-N-US 34MM COMM
MEDTRONIC COREVALVE LLC
ENVEOR-N-US
In Commercial Distribution
- 00643169640337 ()
- Outer Diameter: 6.7 Millimeter
- Length: 107.0 Centimeter
- Aortic transcatheter heart valve bioprosthesis, stent-like framework
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
37200
In Commercial Distribution
- H628372001 ()
37200
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
The Model 2200A-47E Anterior Lead is provided sterile for implantation. It is a flexible lead that contains bipolar platinum/iridium tip and ring electrodes with an insulated lead body. Electrical current is delivered to the tip electrode which is implanted to be in contact with the anterior trunk of the vagus nerve to block nerve signals. The ring electrode is placed in contact with the stomach to measure lead impedance. Sutures are used to anchor and stabilize the lead placement. The lead is connected to the implanted Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
2200A-47E
Not in Commercial Distribution
- 00857334004286 ()
- Length: 47 Centimeter
2200A-47E
- Vagus nerve electrical stimulation system lead
Can be used in place of Cardiac Science™ electrodes part # 9131-001.
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and
not breathing spontaneously. Heart Sync T100-CS AED pads are single use and intended to
be used in conjunction with Cardiac Science automated external defibrillators (AED) to monitor and
deliver defibrillation energy to the patient. The T100-CS AED pads are used on patients over
8 years of age or greater than 55 pounds. The electrodes are intended for short term use (less than 8
hours)
HEART SYNC INC
T100-CS
In Commercial Distribution
- 00868866000004 ()
- 10868866000001 ()
T100-CS
- Electrode conductive skin pad, single-use
The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems. This device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. This device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer.
Beckman Coulter, Inc.
C22845
In Commercial Distribution
- 15099590701673 ()
C22845
- Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay
XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 33 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1804500-33
In Commercial Distribution
- 08717648233678 ()
- Stent Diameter: 5 Millimeter
- Stent Length: 33 Millimeter
1804500-33
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 5.00 mm x 28 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1804500-28
In Commercial Distribution
- 08717648233661 ()
- Stent Length: 28 Millimeter
- Stent Diameter: 5 Millimeter
1804500-28
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated