Continuous Ventilator

GUDID 17290013641363

F60 DL ENG Internal

FLIGHT MEDICAL INNOVATIONS LTD

Anaesthesia ventilator

• Primary Device ID: 17290013641363
• NIH Device Record Key: 1ff40783-34c4-4d44-ac6b-70764dda866d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Continuous Ventilator
• Version Model Number: V100-0004-PK
• Company DUNS: 600023576
• Company Name: FLIGHT MEDICAL INNOVATIONS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	17290013641363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130171

FDA Product Code

• CBK: Ventilator, Continuous, Facility Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-29

On-Brand Devices [Continuous Ventilator]

• 17290013641974: F60T DL ENG-UM
• 17290013641967: F60T DL ENG Int Mixer-UM
• 17290013641950: F60T SL Sym With Interna
• 17290013641943: F60T SL Sym With Interna
• 17290013641936: F60 Turbine Low flow DL
• 17290013641929: F60T DL Sym w Internal Mixer
• 17290013641387: F60 SL ENG Internal
• 17290013641363: F60 DL ENG Internal
• 17290013641264: F60 DL Sym Internal
• 17290013641257: F60 SL Sym Internal Mixer
• 17290013641110: F60 DL Sym-Pad
• 17290013641103: F60 SL Sym-Pad
• 17290013641073: F60 DL Eng-Pad
• 17290013641066: F60 SL Eng-Pad