NeoPod

GUDID 10709078002318

Neo-Pod T LavaBed Kit

WESTMED, INC.

Heated respiratory humidifier

• Primary Device ID: 10709078002318
• NIH Device Record Key: 51465787-7df3-44c3-b1ab-471017aa4a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPod
• Version Model Number: 9409
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078002311 [Primary]
GS1	10709078002318 [Package]; Contains: 00709078002311; Package: [10 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-17

On-Brand Devices [NeoPod]

• 10709078002318: Neo-Pod T LavaBed Kit
• 00709078002304: NeoPod T Transport Test Module
• 10709078002295: Universal, Neonatal, NeoPod Transport Breathing Circuit W/Lavabed
• 10709078002288: Universal, Neonatal, NeoPod Transport Circuit with Exhalation Valve, Lavabed