PEDI
NA - Pedi-Lite Spirometry Kit 3m, M1032634
Device Description
A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.
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: BZK
Device Name: Spirometer, Monitoring (W/Wo Alarm)
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: 868.1850
Third Party Flag: Y
Medical Specialty: AN
Code: CCL
Device Name: Analyzer, Gas, Oxygen, Gaseous-Phase
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: 868.1720
Third Party Flag: Y
Medical Specialty: AN
Code: CBQ
Device Name: Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
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: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: BZL
Device Name: Computer, Oxygen-Uptake
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: 868.1730
Third Party Flag: Y
Medical Specialty: AN
Code: NHQ
Device Name: Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A isoflurane gas analyzer is a device intended to measure the concentration of isoflurane anesthetic in a gas mixture
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: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: CBR
Device Name: Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
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: 868.1700
Third Party Flag: Y
Medical Specialty: AN
Code: NHO
Device Name: Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A desflurane gas analyzer is a device intended to measure the concentration of desflurane anesthetic in a gas mixture.
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: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: CAP
Device Name: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
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: 868.2600
Third Party Flag: Y
Medical Specialty: AN
Code: NHP
Device Name: Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class: 2
Physical State: N/A
Definition: A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture
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: 868.1500
Third Party Flag: Y
Medical Specialty: AN
Code: CBS
Device Name: Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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: 868.1620
Third Party Flag: Y
Medical Specialty: AN
Code: CCK
Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
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: 868.1400
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 20840682102852
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00840682102858
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 00840682102858
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
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