IntelliSpace Perinatal Large Architecture is a software
IntelliSpace Perinatal - IntelliSpace Perinatal K Large Arch.
Device Description
A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of obstetrical services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: HGM
Device Name: System, Monitoring, Perinatal
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OB
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 884.2740
Third Party Flag: Y
Medical Specialty: OB
Code: DSJ
Device Name: Alarm, Blood-Pressure
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1100
Third Party Flag: Y
Medical Specialty: CV
Device Identifiers
Device Id: 00884838084483
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
