Product Overview

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 Identifiers

Device 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


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