AirLife 5097PF

GUDID 50885403293274

AirLife™ PFT Filter

Carefusion Corporation

Pulmonary function testing filter/mouthpiece
Primary Device ID50885403293274
NIH Device Record Key13804984-dec5-40f8-bc25-ce524f14da8c
Commercial Distribution Discontinuation2022-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAirLife
Version Model Number5097PF
Catalog Number5097PF
Company DUNS830432451
Company NameCarefusion Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com
Phone+1(800)323-9088
Emailgmb-MedSpec-CustService@carefusion.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110885403293276 [Primary]
GS150885403293274 [Package]
Contains: 10885403293276
Package: Case [50 Units]
Discontinued: 2022-03-31
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, bacterial, breathing-circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-05-21
Device Publish Date2016-09-21

On-Brand Devices [AirLife]

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

Trademark Results [AirLife]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AIRLIFE
AIRLIFE
97938590 not registered Live/Pending
SunMed Group Holdings, LLC
2023-05-16
AIRLIFE
AIRLIFE
97553332 not registered Live/Pending
Hudson Brands, Inc.
2022-08-17
AIRLIFE
AIRLIFE
86148589 not registered Dead/Abandoned
Techtronic Floor Care Technology Limited
2013-12-19
AIRLIFE
AIRLIFE
85669918 not registered Dead/Abandoned
AIRLIFE CHILE S.A.
2012-07-06
AIRLIFE
AIRLIFE
85253709 4335355 Dead/Cancelled
AIRLIFE CHILE S.A.
2011-02-28
AIRLIFE
AIRLIFE
79309660 not registered Live/Pending
FINAL SPOR VE TEKSTIL SANAYI VE TICARETLIMITED SIRKETI
2020-08-12
AIRLIFE
AIRLIFE
79210163 not registered Dead/Abandoned
FINAL SPOR VE TEKSTIL SANAYI VE TICARETLIMITED SIRKETI
2016-10-18
AIRLIFE
AIRLIFE
78545378 3150546 Live/Registered
CAREFUSION 2200, INC.
2005-01-11
AIRLIFE
AIRLIFE
78534814 3111371 Dead/Cancelled
HENKEL AG & CO. KGAA
2004-12-17
AIRLIFE
AIRLIFE
77830202 not registered Dead/Abandoned
Hewlett-Packard Development Company, L.P.
2009-09-18
AIRLIFE
AIRLIFE
75926229 not registered Dead/Abandoned
AirSep Corporation
2000-02-23
AIRLIFE
AIRLIFE
73353790 not registered Dead/Abandoned
Insurance Concepts, Inc.
1982-03-10

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