68674 software
Spirotrac - 7000
Device Description
An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.
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: BZG
Device Name: Spirometer, Diagnostic
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: AN
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: 868.1840
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 15099169676760
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 65099169686740
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
Device Id: 05099169706064
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676760
Package Quantity: 1
Package Discontinue Date: 1/26/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 15099169676814
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 05099169706118
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676814
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 15099169676777
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 05099169706071
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676777
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 05099169706057
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676753
Package Quantity: 1
Package Discontinue Date: 1/26/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 15099169676753
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 05099169706040
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676746
Package Quantity: 1
Package Discontinue Date: 1/26/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 05099169706026
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676722
Package Quantity: 1
Package Discontinue Date: 1/26/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 15099169676746
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 05099169706125
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676821
Package Quantity: 1
Package Discontinue Date: 1/26/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 15099169676821
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 15099169676722
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 15099169676852
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 15099169676715
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 05099169706156
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676852
Package Quantity: 1
Package Discontinue Date: 1/26/2017 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 05099169706019
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676715
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 05099169706194
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15099169676890
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 15099169676890
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 65099169686740
Package Quantity: 15
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A