Controllers/Accessories

GUDID 00709078012198

Transport Humidifier Mattress Bracket

WESTMED, INC.

Heated respiratory humidifier

• Primary Device ID: 00709078012198
• NIH Device Record Key: fad2fc88-960c-4f32-9e92-88bca904f71c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Controllers/Accessories
• Version Model Number: 4357
• 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: true
• 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	00709078012198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870173

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Controllers/Accessories]

• 00709078012198: Transport Humidifier Mattress Bracket
• 10709078012188: Neo-Pod T Cartridge Bracket
• 00709078012150: Bracket, pole mounting, (Neopod T Accessory)