NeoPad "T" AC to DC Power Supply Cable

GUDID 10709078001922

WESTMED, INC.

Ventilator breathing circuit, single-use

• Primary Device ID: 10709078001922
• NIH Device Record Key: e5bdafd9-aaa6-4ad3-b723-fec6ca2a46b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoPad "T" AC to DC Power Supply Cable
• Version Model Number: 9401
• 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	00709078001925 [Primary]
GS1	10709078001922 [Package]; Contains: 00709078001925; Package: [1 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: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-12-15

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