Infant Resuscitator T-Piece Catheter Access Adapter

GUDID 00854401006365

FLEXICARE MEDICAL LIMITED

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• Primary Device ID: 00854401006365
• NIH Device Record Key: 378152fb-e359-4bfd-bd1f-060c1451152e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Infant Resuscitator T-Piece Catheter Access Adapter
• Version Model Number: NF-055-10U
• 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	00854401006365 [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: 2019-01-23
• Device Publish Date: 2018-12-11

On-Brand Devices [Infant Resuscitator T-Piece Catheter Access Adapter]

• 00854401006365: NF-055-10U
• 05055931119562: NF-055-10U