NeoPod `T` Transport Controller, W/Pole mounting bracket

GUDID 00709078002205

NeoPod `T` Transport Controller, W/Pole mounting bracket

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 00709078002205
• NIH Device Record Key: 43ea3888-1890-4635-96ac-433593784177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPod `T` Transport Controller, W/Pole mounting bracket
• Version Model Number: 4006-1
• 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	00709078002205 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-12-30

On-Brand Devices [NeoPod `T` Transport Controller, W/Pole mounting bracket]

• 00709078002229: NeoPod `T` Transport Controller, W/Pole mounting bracket
• 00709078002205: NeoPod `T` Transport Controller, W/Pole mounting bracket