NeoPod

GUDID 10709078002295

Universal, Neonatal, NeoPod Transport Breathing Circuit W/Lavabed

WESTMED, INC.

Heated respiratory humidifier

• Primary Device ID: 10709078002295
• NIH Device Record Key: 8c2c905e-fe24-40bd-813b-b4b2b7f9d093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPod
• Version Model Number: 9402
• 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	00709078002298 [Primary]
GS1	10709078002295 [Package]; Contains: 00709078002298; Package: [20 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: 2016-12-30

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