VentiShield Adult Bacterial Viral Filter

GUDID 05055788772262

FLEXICARE MEDICAL LIMITED

Microbial medical gas filter, sterile, single-use

• Primary Device ID: 05055788772262
• NIH Device Record Key: c6647dda-3944-40c3-b29e-05ef82ca732b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VentiShield Adult Bacterial Viral Filter
• Version Model Number: 038-41-360STRU
• Company DUNS: 504406273
• Company Name: FLEXICARE MEDICAL LIMITED
• 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: false
• Expiration Date: true
• 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	05055788772262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092218

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-12

On-Brand Devices [VentiShield Adult Bacterial Viral Filter]

• 05055788772262: 038-41-360STRU
• 05055788770190: With Oxygen / Nitrous Oxide Circuit Mouthpiece