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To spot check or monitor Oxygen saturation of arterial hemoglobin (SpO2%) and pulse rate. To analyze the pulse waveform (Photoelectrical Plethysmography or PP) provided by the oximeter. It only provides mathematical analyses of the input of the SpO2 measurement. To analyze the basic rhythms of the NN or RR intervals in heart rate, both in the time domain and in the frequency domain (short time 5 minutes). It only provides mathematical analysis of the input of the heart rate variability. The mathematical analysis of Photoelectrical Plethysmography and HRV ARE NOT intended use for diagnosis. The software provides a visual alarm for the values of the heart rate and/or SpO2 percent out of the normal range and for the bad quality signal transmission. The data are stored in PC in the Backup system of the LD-Oxi software. The device is intended use only for adult subjects (> 20 years old) This Oximeter is intended to be used in spot-checking (5 minutes). The device is intended use in licensed practitioner’s office This device is no intended to be used at home, in hospital or out-of-hospital transport The device is not intended use in support life and not for continuously monitoring The system will be use by practitioner.
LD TECHNOLOGY, LLC
D001
In Commercial Distribution
- B322D0011 ()
- Pulse oximeter, line-powered
The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
SM9Z9461G
In Commercial Distribution
- 00845533000451 ()
SM9Z9461G
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
Q9Z9461GB
In Commercial Distribution
- 00845533000444 ()
Q9Z9461GB
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.
ZEUS SCIENTIFIC, INC.
9Z9461G
In Commercial Distribution
- 00845533000437 ()
9Z9461G
- Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
The standard rearfoot screw is used in the Integra Total Foot System. It is made from titanium and is non-locking.
Ascension Orthopedics, Inc.
2845150
In Commercial Distribution
- 10381780118688 ()
- M26828451501 ()
- 50 mm L x 3.5 mm dia
2845150
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The standard rearfoot screw is used in the Integra Total Foot System. It is made from titanium and is non-locking.
Ascension Orthopedics, Inc.
2845145
In Commercial Distribution
- 10381780118671 ()
- M26828451451 ()
- 45 mm L x 3.5 mm dia
2845145
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The standard rearfoot screw is used in the Integra Total Foot System. It is made from titanium and is non-locking.
Ascension Orthopedics, Inc.
2845140
In Commercial Distribution
- 10381780118664 ()
- M26828451401 ()
- 40 mm L x 3.5 mm dia
2845140
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The standard rearfoot screw is used in the Integra Total Foot System. It is made from titanium and is non-locking.
Ascension Orthopedics, Inc.
2845135
In Commercial Distribution
- 10381780118657 ()
- M26828451351 ()
- 35 mm L x 3.5 mm dia
2845135
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The standard rearfoot screw is used in the Integra Total Foot System. It is made from titanium and is non-locking.
Ascension Orthopedics, Inc.
2845132
In Commercial Distribution
- 10381780118640 ()
- M26828451321 ()
- 32 mm L x 3.5 mm dia
2845132
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The standard rearfoot screw is used in the Integra Total Foot System. It is made from titanium and is non-locking.
Ascension Orthopedics, Inc.
2845130
In Commercial Distribution
- 10381780118633 ()
- M26828451301 ()
- 30 mm L x 3.5 mm dia
2845130
- Orthopaedic bone screw, non-bioabsorbable, non-sterile