Adult Smoothbore Single Limb H/W B/c Kit 1.6M (63") (Kit 1)

GUDID 05055788708599

FLEXICARE MEDICAL LIMITED

Ventilator breathing circuit, single-use

• Primary Device ID: 05055788708599
• NIH Device Record Key: 8ce81832-de37-4248-90fd-8c581569c425
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Smoothbore Single Limb H/W B/c Kit 1.6M (63") (Kit 1)
• Version Model Number: 038-31-601U
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055788708599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150900

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-10-04

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