Composite Respiratory Kit

GUDID 10709078007788

Composite Respiratory Kit

WESTMED, INC.

Nebulizing system delivery set, reusable

• Primary Device ID: 10709078007788
• NIH Device Record Key: 87460ab2-3de6-4be2-a438-16296e42b014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Composite Respiratory Kit
• Version Model Number: 0799
• 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: true
• 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	00709078007781 [Primary]
GS1	10709078007788 [Package]; Contains: 00709078007781; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800562

FDA Product Code

• OGG: Humidifier Nebulizer Kit

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: 2019-10-28
• Device Publish Date: 2019-10-18

On-Brand Devices [Composite Respiratory Kit]

• 10709078005708: O2 Composite Kit
• 10709078003612: 1 - Packaged 50' O2 Tubing (0052), 6 - Packaged Soft Cannula with 7' Tubing (0556), 1 - Barbed C
• 10709078005968: 0798
• 10709078007788: Composite Respiratory Kit