Standard Preformed Oral South(POS)ET Tube ID 5.5 -

GUDID 05055788707813

FLEXICARE MEDICAL LIMITED

Basic endotracheal tube, single-use

• Primary Device ID: 05055788707813
• NIH Device Record Key: 08544a6e-2340-496a-bed5-d24296b06528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Preformed Oral South(POS)ET Tube ID 5.5 -
• Version Model Number: 038-982-055U
• 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	05055788707813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091591

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

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: 2016-10-04

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