HepaShield Adult Pleated Hydrophobic Bacterial Viral Filter

GUDID 05055788772286

FLEXICARE MEDICAL LIMITED

Microbial medical gas filter, non-sterile, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use Microbial medical gas filter, single-use

• Primary Device ID: 05055788772286
• NIH Device Record Key: 1baf00c0-d553-49cd-8456-e7c99187ad3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HepaShield Adult Pleated Hydrophobic Bacterial Viral Filter
• Version Model Number: 038-41-370U
• 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	05055788772286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191909

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2020-04-06
• Device Publish Date: 2020-03-27

On-Brand Devices [HepaShield Adult Pleated Hydrophobic Bacterial Viral Filter]

• 05055931102335: 038-41-370STRU
• 05055788772286: 038-41-370U