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510(k) Data Aggregation
K Number
K974248Device Name
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
Manufacturer
AIR-SHIELDS, INC.
Date Cleared
1998-10-07
(329 days)
Product Code
HGM
Regulation Number
884.2740Why did this record match?
Applicant Name (Manufacturer) :
AIR-SHIELDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WatchChild™ System is a complete Obstetrical Information Management System which has the ability to record, store, and display data from fetal monitors and maternal vital signs monitors, and manages patient information from the initial Fetal Stress Tests through post delivery discharge. WatchChild organizes clinical data which would normally be provided on paper records or other clinical systems and devices. This system serves as a decision support tool as well as an electronic medical record. This device is intended for use in a hospital/clinical environment.
Device Description
The WatchChild™ Obstetrical Patient Data Management System is a data management system that interfaces with patient monitoring equipment to record, display and/or archive the data. The system is a computer based system that contains software for easy data storage and retrieval of fetal/maternal data. The system is comprised of, in addition to the software, an IBM RISC System/6000, redundant disk drives to assure reproducibility of information, X-terminal graphics workstation, optical disk drive, and laser printer. WatchChild archives all fetal monitor data, maternal hemodynamic and waveform data (NIBP and SaO2), patient charting, admission forms, examinations, flowsheets, medications, lab results, discharge information, and notes. WatchChild automatically reads NIBP, SaO,, and heart rate at hospital defined intervals.
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K Number
K972309Device Name
JM-102 JAUNDICE METER
Manufacturer
AIR-SHIELDS, INC.
Date Cleared
1998-09-22
(459 days)
Product Code
MQM, MOM
Regulation Number
862.1113Why did this record match?
Applicant Name (Manufacturer) :
AIR-SHIELDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The JM-102 Jaundice Meter is a diagnostic device intended for use on infants suspected of having jaundice to provide an objective index of icterus. This index can be used by a medical practitioner to identify infants who should be given a serum bilirubin test and to identify those infants who do not need a serum test.
The JM-102 Jaundice Meter provides an objective index of icterus in infants and when used in conjunction with other clinical signs and/or laboratory measurements, can assist the physician in making clinical decisions regarding the need for serum bilirubin measurements medior therep
Device Description
The Air-Shields JM-102 Jaundice Meter is a hand-held non-invasive device for the measurement of the level of jaundice in an infant. The system consists of the hand-held meter with digital display, the charger for recharging the NiCd battery pack in the device, a calibration checker, and a carrying case. The device measures the yellowish tint in jaundiced skin by analyzing the light reflected off the skin. The fiberoptic probe on top of the device is held against the infant's skin and an internal flash lamp sends a pulse of light through the outer part of an optical wave guide to the skin where the light is reflected back through the inner part of the optical wave guide and to the spectral analysis section of the device.
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K Number
K971256Device Name
DUO-LITE PHOTOTHERAPY SYSTEM
Manufacturer
AIR-SHIELDS, INC.
Date Cleared
1997-09-24
(173 days)
Product Code
LBI, BLI
Regulation Number
880.5700Why did this record match?
Applicant Name (Manufacturer) :
AIR-SHIELDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DUO-LITE™ Phototherapy System is designed to provide treatment in the form of Phototherapy to those infants that have been identified as having elevated bilirubin levels (hyperbilirubinemia). Phototherapy as a means for reducing bilirubin levels is a well established treatment modality. The output of the light has been optimized for maximum absorption by the skin in order to reduce the bilirubin levels as quickly as possible.
The DUO-LITE™ Phototherapy System provides the option to select white or blue light via a selector switch. This provides the caregiver with the option to give high output phototherapy for some infants (or early in the treatment cycle) followed by more moderate phototherapy for other infants (or later in the treatment cycle). By contrast, other phototherapy lamp products give the option of either White or Blue light which needs to be set up by an engineer in advance of the treatment. The DVO-LITE™ has combined these two light sources into one housing for the convenience of the caregiver.
The DUO-LITE™ Phototherapy System can be placed on the hood of an infant incubator, mounted on the Air-Shields Rail System, or positioned over an open warming bed or crib.
Device Description
The DUO-LITE" Phototherapy System provides light output for maximum absorption by the infant's skin in order to reduce bilirubin levels. The DUO-LITE™ is designed for use in conjunction with a variety of other products. Perhaps the most common application is when placed on the hood of an incubator, or fitted to a rail system and appitioned over the hood of the incubator. The DUO-LITT:" can also be mounted to a mobile stand, thus extending its applications to use with Open Warmers and Open Bassinets.
The product is L 23 x W 10 x H 5 (inches) and weighs approximately 15 Lbs. It is available in 100, 120 and 220/240V 50/60 Hz. The DUO-LITE™ is comprised of three 75W quartz halogen bulbs. The light emitted from these bulbs is filtered through IR/UV and Dichroic filters. The output of the bulbs is dependent on the driving voltage which is regulated by the internal power supply.
The user can select the use of White light or Blue light using the selector switch on the front of the lamp housing. The different color lights give different therapeutic outputs depending on the individual needs of the patient. Adjacent to the On/Off switch is a digital counter which can be set to display exposure time and bulb life remaining.
The DU1)-LIT!:" uses quartz halogen technology since the irradiance remains constant over the life of the bulb. By way of comparison, fluorescent bulbs degrade rapidly over the course of time and as such need to be continually monitored to ensure the output is therapeutically acceptable.
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K Number
K960980Device Name
ISOLETTE INFANT INCUBATOR
Manufacturer
AIR-SHIELDS, INC.
Date Cleared
1996-07-30
(141 days)
Product Code
FMZ
Regulation Number
880.5400Why did this record match?
Applicant Name (Manufacturer) :
AIR-SHIELDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K924709Device Name
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
Manufacturer
AIR-SHIELDS, INC.
Date Cleared
1996-01-17
(1216 days)
Product Code
KLK
Regulation Number
868.2500Why did this record match?
Applicant Name (Manufacturer) :
AIR-SHIELDS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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