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Found 10 results
510(k) Data Aggregation
K Number
K133450Device Name
AIRSTRIP REMOTE PATIENT MONITORING
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2014-02-14
(95 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
· By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
- · To view the near real-time waveforms remotely
- · To remotely review other standard or critical near real-time patient data from the monitored system
· To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the physiologic data captured by other medical devices:
- · ECG Waveform
- · Heart Rate Monitored
- · Respiratory Rate
- · Oxygen Saturation
- · Intracranial Pressure
- · Central Venous Pressure
- · Pulmonary Capillary Wedge Pressure
- Cardiac Index
- · Cardiac Output
- · Cerebral Perfusion Pressure
- · Urine Output
- · Urine/Stool Mix Output
- · Systolic Blood Pressure Invasive
- · Mean Arterial Pressure Invasive
- · Diastolic Blood Pressure Invasive
- · Systolic Blood Pressure Cuff
- · Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
- · Vasoactive Infusions
- · Antiarrhythmics
- · Sedation
- · Paralvtics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- · Allergies
- · Medications
Device Description
AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
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K Number
K133394Device Name
AIRSTRIP REMOTE PATIENT MONITORING
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2014-02-06
(93 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K131786Device Name
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2013-07-03
(15 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
· By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
· To view the near real-time waveforms remotely
· To remotely review other standard or critical near real-time patient data from the monitored system
· To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
- · ECG Waveform
- · Heart Rate Monitored
- · Respiratory Rate
- · Oxygen Saturation
- · Intracranial Pressure
- · Central Venous Pressure
- · Pulmonary Capillary Wedge Pressure
- · Cardiac Index
- · Cardiac Output
- · Cerebral Perfusion Pressure
- · Urine Output
- Urine/Stool Mix Output
- · Systolic Blood Pressure Invasive
- · Mean Arterial Pressure Invasive
- · Diastolic Blood Pressure Invasive
- · Systolic Blood Pressure Cuff
- · Mean Arterial Pressure Cuff
- · Diastolic Blood Pressure Cuff
-
- · Vasoactive Infusions · Antiarrhythmics
-
- · Sedation
- · Paralytics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- · Allergies
- · Medications
Device Description
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
Ask a Question
K Number
K122133Device Name
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2012-10-02
(76 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
• By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
· To view the near real-time waveforms remotely
· To remotely review other standard or critical near real-time patient data from the monitored system
• To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the physiologic data captured by other medical devices:
- · ECG Waveform
- · Heart Rate Monitored
- · Respiratory Rate
- · Oxygen Saturation
- · Intracranial Pressure
- · Central Venous Pressure
- · Pulmonary Capillary Wedge Pressure
- Cardiac Index
- · Cardiac Output
- · Cerebral Perfusion Pressure
- · Urine Output
- · Urine/Stoo! Mix Output
- · Systolic Blood Pressure Invasive
- · Mean Arterial Pressure Invasive
- · Diastolic Blood Pressure Invasive
- · Systolic Blood Pressure Cuff
- · Mean Arterial Pressure Cuff
- · Diastolic Blood Pressure Cuff
- · Vasoactive Infusions
- Antiarrhythmics
- Sedation
- · Paralytics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coaqulation
- · Allergies
- · Medications
Counter-Indications
Ocamer manageno intended for use anywhere cellular telephones or wireless devices are prohibited. AirStrip RPM is intended for use the hour when they cannot be at the hospital. AirStrip RPM is intended for use by clinicians as a diagnostic aid, and not as a replacement for direct viewing of any of the monitoring devices from which it obtains its data.
Device Description
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
Ask a Question
K Number
K121871Device Name
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2012-07-03
(6 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and not by AirStrip RPM. AirStrip RPM. AirStrip RPM generated by other medical devices and patential and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
• By using a cellular telephone or other device on which AirStrip RPM is installed, to review phy patient when the clinician is not at the hospital
• To view the near real-time waveforms remotely
• To remotely review other standard or critical near real-time payafam as ather deta
• To remotely review other standard of entilour roar time patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
• Heart Rate Monitored
• Respiratory Rate
• Oxygen Saturation
• Intracranial Pressure
• Central Venous Pressure
• Pulmonary Capillary Wedge Pressure
• Cardiac Index
• Cardiac Output
• Cerebral Perfusion Pressure
• Urine Output
• Urine/Stool Mix Output
• Systolic Blood Pressure Invasive
• Mean Arterial Pressure Invasive
• Diastolic Blood Pressure Invasive
• Systolic Blood Pressure Cuff
• Mean Arterial Pressure Cuff
• Diastolic Blood Pressure Cuff
• Vasoactive Infusions
• Antiarrhythmics
• Sedation
• Paralytics
• Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coaqulation
• Alleraies
• Medications
Device Description
AirStrip Remote Patient Monitoring (RPM) Remote Data Viewing software
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K Number
K112235Device Name
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2011-08-26
(22 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
· By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
- · To view the near real-time waveforms remotely
- · To remotely review other standard or critical near real-lime patient data from the monitored system
- · To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the physiologic data captured by other medical devices:
- · ECG Waveform
- · Heart Rate Monitored
- · Respiratory Rate
- · Oxygen Saturation
- · Intracranial Pressure
- · Central Venous Pressure
- · Pulmonary Capillary Wedge Pressure
- Cardiac Index
- · Cardiac Output
- · Cerebral Perfusion Pressure
- · Urine Output
- · Urine/Stool Mix Output
- · Systolic Blood Pressure Invasive
- · Mean Arterial Pressure Invasive
- · Diastolic Blood Pressure Invasive
- · Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff
- · Diastolic Blood Pressure Cuff
- · Vasoactive Infusions
- · Antiarrhvthmics
- · Sedation
- · Paralvtics
- · Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- · Allergies
- · Medications
Device Description
AirStrip RPM is software capable of displaying physiologic and other patient information is generated by other medical devices and patient information system, and not by AirStrip RPM captures this information from these other systems and displays it for clinicians.
Ask a Question
K Number
K110503Device Name
AIRSTRIP REMOTE PATIENT MONITORING (RPM)
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2011-03-10
(16 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
• By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
- To view the near real-time waveforms remotely
- To remotely review other standard or critical near real-time patient data from the monitored system
- To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the physiologic data captured by other medical devices:
- ECG Waveform
- Heart Rate Monitored
- Respiratory Rate
- Oxygen Saturation
- Intracranial Pressure
- Central Venous Pressure
- Pulmonary Capillary Wedge Pressure
- Cardiac Index
- Cardiac Output
- Cerebral Perfusion Pressure
- Urine Output
- Urine/Stool Mix Output
- Systolic Blood Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Blood Pressure Invasive
- Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
- Vasoactive Infusions
- Antiarrhythmics
- Sedation
- Paralytics
- Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- Allergies
- Medications
Device Description
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
Ask a Question
K Number
K100133Device Name
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING SOFTWARE, VERSION 3.1
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2010-07-23
(185 days)
Product Code
MWI
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip RPM is software capable of displaying physiologic and other patient information. This information is generated by other medical devices and patient information system, and not by AirStrip RPM. AirStrip RPM captures this information from these other systems and displays it for clinicians.
AirStrip RPM is intended to be used by clinicians for the following purposes:
- By using a cellular telephone or other device on which AirStrip RPM is installed, to review physiologic data of a patient when the clinician is not at the hospital
- To view the near real-time waveforms remotely
- To remotely review other standard or critical near real-time patient data from the monitored system
- To provide a request for remote consultation regarding a patient's waveform or other data
The AirStrip RPM software can display the following the physiologic data captured by other medical devices:
- ECG Waveform
- Blood Pressure Waveform
- 02 Waveform
- CO2 Waveform
- Heart Rate
- Respiratory Rate
- Oxygen Saturation
- Intracranial Pressure
- Central Venous Pressure
- Pulmonary Capillary Wedge Pressure
- Cardiac Index
- Cardiac Output
- Cerebral Perfusion Pressure
- Urine Output
- Urine/Stool Mix Output
- Systolic Blood Pressure Invasive
- Mean Arterial Pressure Invasive
- Diastolic Blood Pressure Invasive
- Systolic Blood Pressure Cuff
- Mean Arterial Pressure Cuff
- Diastolic Blood Pressure Cuff
- Vasoactive Infusions
- Antiarrhythmics
- Sedation
- Paralytics
- Laboratory Data including
- Blood Gas
- Chemistry
- Hematology
- Coagulation
- Allergies
- Medications
Device Description
AirStrip RPM is software that runs on devices capable of running Apple iPhone OS. It interfaces with third-party centralized monitoring systems that in turn gather data from patient monitors and other devices in the hospital. AirStrip RPM gives health care providers the ability to view near-real-time patient physiological data remotely.
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K Number
K090269Device Name
AIRSTRIP OB
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2009-02-13
(10 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip OB® is intended to be used by Obstetricians for the following purposes:
To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device
To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time.
To review the current Labor and Delivery patient census list.
Provide a request for remote consultation regarding a fetal heart tracing.
To remotely review other standard or critical real-time numeric data from Labor and Delivery.
Device Description
Not Found
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K Number
K090061Device Name
AIRSTRIP OB
Manufacturer
AIRSTRIP TECHNOLOGIES, LP
Date Cleared
2009-01-23
(14 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
AIRSTRIP TECHNOLOGIES, LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AirStrip OB® is intended to be used by Obstetricians for the following purposes
To more rapidly and thoroughly respond to a nurse call regarding fetal heart tracings or maternal contraction patterns by viewing the real time waveforms remotely using a Windows-based handheld device
To proactively review a fetal heart or maternal contraction tracing of a patient in Labor and Delivery for whom they are responsible but are unable to be present in the hospital at that time
To review the current Labor and Delivery patient census list
Provide a request for remote consultation regarding a fetal heart tracing
To remotely review other standard or critical real-time numeric data from Labor and Delivery
Device Description
Not Found
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