LTV 15090-104

GUDID 50190752201437

Patient Circuit, W/O PEEP, 15mm, SPU, Single Heated Wire, F&P

VYAIRE MEDICAL, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 50190752201437
• NIH Device Record Key: 4b302c56-3885-400f-9ea2-57fae22736ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LTV
• Version Model Number: 15090-104
• Catalog Number: 15090-104
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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 -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10190752201439 [Primary]
GS1	50190752201437 [Package]; Contains: 10190752201439; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101643

FDA Product Code

• CBK: Ventilator, continuous, facility use

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-20
• Device Publish Date: 2024-08-12

On-Brand Devices [LTV]

• 50190752146530: Patient Circuit, W/PEEP, W/1 Water Trap, 15mm, SPU
• 10190752130241: Freedom Carrier for LTV & Sprintpack
• 10190752130159: Remote Alarm Cable NC W/BNC Coiled
• 10190752130142: Patient Circuit W/O PEEP, 15mm, Reusable
• 10190752130074: LTM Splitter Cable
• 10190752129993: LTV Backpack
• 10190752129634: Nurse Call Cable, Normally Closed
• 10190752129627: Patient Circuit Ventilator Adapter
• 10190752129306: LTV FLOOR STAND
• 50190752118070: Patient Circuit, W/O PEEP, 15mm, SPU, Dual Heated Wire, F&P
• 50190752118025: Patient Circuit, W/PEEP, 15mm, SPU, Dual Heated Wire, F&P
• 50190752118018: Patient Circuit, W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P
• 50190752118001: Patient Circuit, W/PEEP, 22mm, SPU, Dual Heated Wire, F&P
• 50190752117998: Patient Circuit, W/O PEEP, 15mm, SPU, Single Heated Wire, F&P
• 50190752117981: Patient Circuit, W/PEEP, 15mm, SPU, Single Heated Wire, F&P
• 50190752117974: Patient Circuit, W/O PEEP, 22mm, SPU, Single Heated Wire, F&P
• 50190752117967: Patient Circuit, W/PEEP, 22mm, SPU, Single Heated Wire, F&P
• 50190752117899: Patient Circuit, W/PEEP, W/1 Water Trap, 22mm, SPU
• 50190752117882: Patient Circuit, W/O PEEP, 15mm, SPU
• 50190752117875: Patient Circuit, W/O PEEP, 22mm, SPU
• 50190752117868: Patient Circuit, W/ PEEP, 15mm, SPU
• 50190752117851: Patient Circuit, W/ PEEP, 22mm, SPU
• 50190752117844: Exhalation Valve Assembly
• 50190752117837: Exhalation Valve Assembly
• 50190752116052: Patient Circuit W/ PEEP, W/1 Water Trap, 22mm, SPU
• 50190752116014: Patient Circuit W/ PEEP, W/1 Water Trap, 15mm, SPU
• 50190752115994: Patient Circuit W/O PEEP, 22mm, SPU, 15'
• 50190752115932: Patient Circuit W/O PEEP, 22mm, SPU
• 50190752115925: Patient Circuit, W/O PEEP, W/1 Water Trap, 15mm, SPU
• 10190752115705: LTV Sprintpack Ext Battery
• 10190752115699: LTV SprintPack Power Manager W/Bracket
• 10190752115682: LTV Sprintpack w/Bracket
• 10190752115668: SprintPack Transport Pack For Use With LTV
• 10190752115248: LTM Graphics Monitor
• 10190752115231: A/C Power Adapter
• 10190752114623: External Battery Kit
• 10190752114555: Oxygen Canister Ring, LTV Rolling Stand
• 10190752114548: Battery Mount, LTV Rolling Stand
• 10190752114500: Basket, LTV Rolling Stand
• 50190752146523: Patient Circuit, W/O PEEP, W/1 Water Trap, 22mm, SPU
• 10190752139268: Desktop Charger, LTV2, English
• 10190752130043: High Pressure Oxygen Blender Kit
• 50190752116120: Patient Circuit W/ PEEP, 22mm, SPU
• 50190752116113: Patient Circuit W/ PEEP, 15mm, SPU
• 50190752116106: Patient Circuit W/O PEEP, 15mm, SPU, Dual Heated Wire, F&P
• 50190752116090: Patient Circuit W/O PEEP, 22mm, SPU, Dual Heated Wire, F&P
• 50190752116007: Patient Circuit W/ PEEP, 22mm, SPU
• 50190752115987: Patient Circuit W/O PEEP, W/1 Water Trap, 22mm, SPU
• 50190752115970: Patient Circuit W/O PEEP, W/1 Water Trap, 15mm, SPU
• 50190752115949: Patient Circuit W/O PEEP, 15mm, SPU