Infant Resuscitation Kit T-Piece Circuit 1.8m (70") with Anatomical Mask Size 1

GUDID 05055788776680

FLEXICARE MEDICAL LIMITED

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• Primary Device ID: 05055788776680
• NIH Device Record Key: f26ec297-e28b-4702-902a-1f9efdea7e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Resuscitation Kit T-Piece Circuit 1.8m (70") with Anatomical Mask Size 1
• Version Model Number: 2109061-001
• 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	05055788776680 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103833

FDA Product Code

• BYE: Attachment, Breathing, Positive End Expiratory Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-07-27

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