Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63")

GUDID 05055788770022

FLEXICARE MEDICAL LIMITED

Carpal lunate prosthesis

• Primary Device ID: 05055788770022
• NIH Device Record Key: 38b3fbae-b53b-4590-82d0-9177ff5c6ffb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63")
• Version Model Number: 038-33-253U
• 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	05055788770022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160540

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

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: 2018-02-12

On-Brand Devices [Neonatal Ventimyst Dual Heated Wire B/S 1.6m (63")]

• 05055788770039: 038-33-255U
• 05055788770022: 038-33-253U
• 05055788770015: 038-33-252U