Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit

GUDID 10709078005463

WESTMED, INC.

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• Primary Device ID: 10709078005463
• NIH Device Record Key: 768ffe7d-be05-416e-be4f-71533bf76ac2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit
• Version Model Number: A9242
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078005466 [Primary]
GS1	10709078005463 [Package]; Contains: 00709078005466; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904538

FDA Product Code

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

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: 2019-12-24
• Device Publish Date: 2018-06-25

On-Brand Devices [Anapod™ Humi-therm Heated and Humidified Wick Breathing Circuit]

• 10709078005463: A9242
• 00709078005381: 48" Heated Humidified Transport Circuit
• 10709078004497: Adult Heated Humidified Circuit, expandable up to 96"