AirLife 5097PF

GUDID 50885403293274

AirLife™ PFT Filter

Carefusion Corporation

Pulmonary function testing filter/mouthpiece

• Primary Device ID: 50885403293274
• NIH Device Record Key: 13804984-dec5-40f8-bc25-ce524f14da8c
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AirLife
• Version Model Number: 5097PF
• Catalog Number: 5097PF
• Company DUNS: 830432451
• Company Name: Carefusion Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com
• Phone: +1(800)323-9088
• Email: gmb-MedSpec-CustService@carefusion.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885403293276 [Primary]
GS1	50885403293274 [Package]; Contains: 10885403293276; Package: Case [50 Units]; Discontinued: 2022-03-31; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033008

FDA Product Code

• CAH: Filter, bacterial, breathing-circuit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-21
• Device Publish Date: 2016-09-21

On-Brand Devices [AirLife]

• 70885403276639: AirLife™ Connector 15 mm OD x 15 mm OD
• 70885403276622: AirLife™ Connector 15 mm ID x 22 mm ID
• 70885403276578: AirLife™ One-way valve 22 mm ID x 22 mm OD with directional idicator arrow
• 70885403276561: AirLife™ Connector 22 mm ID x 22 mm ID
• 50885403199132: Airlife™ Nebulizer Heater
• 50885403164888: Airlife™ Modudose™ Sterile Water for Inhalation, USP, 3 ml
• 50885403167261: Airlife™ Modudose™ 0.45% Sodium Chloride Solution for Inhalation, USP, 5 ml
• 50885403164871: Airlife™ Modudose™ Sterile Water for Inhalation, USP, 5 ml
• 50885403164840: Airlife™ Modudose™ 0.9% Sodium Chloride Solution, USP, 5 ml
• 50885403164833: Airlife™ Modudose™ 0.9% Sodium Chloride Solution, USP, 3 ml
• 50885403164819: Airlife™ Prefill Nebulizer Kit Nebulizer Cap and 0.45% Sodium Chloride Sterile Inhalation
• 50885403164796: Airlife™ Prefill Nebulizer Kit Nebulizer Cap and 0.45% Sodium Chloride Sterile Inhalation
• 50885403164574: Airlife™ 0.45% Sodium Chloride Inhalation Solution, USP 1000 ml
• 50885403164543: Airlife™ 0.45% Sodium Chloride Inhalation Solution, USP 500 ml
• 50885403164581: Airlife™ Sterile Water for INHALATION, USP 1000 ml
• 50885403164598: Airlife™ Sterile Water for INHALATION, USP 500 ml
• 50885403199170: Airlife™ Sterile Water for INHALATION, USP With spikable cap and hanger
• 50885403199163: Airlife™ 0.9% Sodium Chloride INHALATION Solution, USP 1000ml
• 50885403199156: Airlife™ Prefill Nebulizer Kit Nebulizer Cap and 0.9% Sodium Chloride Sterile Inhalation S
• 50885403164826: Airlife™ Sterile Water for INHALATION, USP With spikable cap and hanger
• 50885403071636: Airlife™ Sterile 0.9% Sodium Chloride for Irrigation, USP, 110 ml
• 50885403071629: Airlife™ Sterile 0.9% Sodium Chloride for Irrigation, USP, 85 ml
• 50885403071612: Airlife™ Sterile Water for Irrigation, USP, 110 ml
• 50885403071605: Airlife™ Sterile Water for Irrigation, USP, 85 ml
• 50885403070981: Airlife™ Sterile Water for Inhalation, USP, 500 ml.
• 50885403070974: Airlife™ Prefilled Humidifier. Sterile Water for Inhalation, USP, 750 ml
• 50885403070950: Airlife™ Prefilled Humidifier. Sterile Water for Inhalation, USP, 750 ml With Humidifier A
• 50885403070943: Airlife™ Prefilled Humidifier. Sterile Water for Inhalation, USP, 500 ml
• 50885403026612: Airlife™ Sterile Water for Inhalation, USP 1000 ml
• 50885403026605: Airlife™ Sterile water for Inhalation, USP 2000 ml
• 50885403001015: Airlife™ Nebulizer with Air Entrainment
• 50885403416680: AirLife Adult Heated Wire Circuit Dual-limb, Dual-heated Circuit
• 50885403416666: AirLife Adult Heating wire circuit single-limb, single-heated circuit
• 50885403288911: AirLife Infant Single Limb Heated Wire Circuit single-limb, single-heat, continuous-flow circuit
• 50885403287075: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min)
• 50885403276222: AirLife Adult Heated Wire Circuit Dual-limb, Dual-heated Circuit
• 50885403276208: AirLife Adult Heated Wire Circuit Single-limb, Single-heated Circuit
• 50885403276192: AirLife Infant Single Limb Heated Wire Circuit single-limb, single-heat, continuous-flow circuit
• 50885403276178: AirLife Infant Heated Wire Circuit dual-limb, dual-heat, high-flow circuit (>4 L/min)
• 50885403199422: Airlife™ Isothermal Breathing Circuit Pediatric Respiratory Circuit Heated
• 50885403198876: Airlife™ Isothermal™ Adult Respiratory Breathing Circuit Heated
• 50885403198869: Airlife™ Isothermal Adult Respiratory Breathing Circuit Heated MR850
• 50885403192775: Airlife™ Isothermal Breathing Circuit Pediatric Respiratory Circuit Heated
• 50885403171381: Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Heated
• 50885403171039: Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit Non-heated, MR850
• 50885403169654: Airlife™ Isothermal™ Breathing Circuit Accessory - Mini - Temp Thermometers
• 50885403169258: Airlife™ Isothermal™ Breathing Circuit Accessory - Rebreather Gasket
• 50885403169036: Airlife™ Isothermal™ Breathing Circuit Accessory - 22m Blue Cap
• 50885403168930: Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit MR850
• 50885403168657: Airlife™ Isothermal™ Breathig Circuit Accessory - 10mm Inspiratory Line Extension