AirLife™ 5097PF

GUDID 50190752147285

AirLife™ PFT Filter

VYAIRE MEDICAL, INC.

Microbial medical gas filter, single-use

• Primary Device ID: 50190752147285
• NIH Device Record Key: 46a493d3-a0ea-418c-bbad-87bd52b067fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirLife™
• Version Model Number: 5097PF
• Catalog Number: 5097PF
• Company DUNS: 080456871
• Company Name: VYAIRE MEDICAL, INC.
• 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: true
• 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(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.com
• Phone: +1(833)327-3284
• Email: customersupport@vyaire.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752147287 [Primary]
GS1	50190752147285 [Package]; Contains: 10190752147287; Package: Case [50 Units]; 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: 2
• Public Version Date: 2020-09-22
• Device Publish Date: 2019-12-20

On-Brand Devices [AirLife™]

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• 50190752131536: AirLife™ Bacterial/Viral Filter
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• 50190752146875: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146202: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146196: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146189: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146172: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146165: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146158: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146141: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146134: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146127: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146110: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146103: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146080: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146073: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146066: AirLife™ flow-inflating tail-end valve transport circuit
• 50190752146059: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752146042: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752146035: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752146028: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752146004: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145991: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145984: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145977: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145960: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145953: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752145946: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752145939: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752145922: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752145908: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752145892: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145885: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145861: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145854: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145847: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145823: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145809: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145793: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145786: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145762: AirLife™ baby safe flow-inflating resuscitation device 1 Liter Bag
• 50190752145755: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145748: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145731: AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag
• 50190752145397: AirLife™ "Baffled" Tee Adapter 22 mm O.D. Arms, 18 mm Base Designed for use with Small Nebuliz
• 50190752145380: AirLife™ Tee Adapter and Universal Mouthpiece With 22 mm O.D. Arms, 18 mm Base Designed for Us
• 50190752145373: AirLife™ Tee adapter With One Arm 22 mm I.D., One Arm 22 mm O.D., 18 mm I.D. Base with Mouthpi