Circulaire II PEP Accessory Kit

GUDID 00709078000775

0262 PEP Accessory Kit 0336 Circulaire II Aerosol Drug Delivery System

WESTMED, INC.

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• Primary Device ID: 00709078000775
• NIH Device Record Key: a7cc4071-37b2-4b69-b4dc-2bb8bf007c71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulaire II PEP Accessory Kit
• Version Model Number: 0338
• 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: true
• 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	00709078000775 [Primary]
GS1	10709078000772 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926055

FDA Product Code

• CAF: Nebulizer (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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-11-24

On-Brand Devices [Circulaire II PEP Accessory Kit]

• 00709078000829: with extra reservoir bag
• 00709078000775: 0262 PEP Accessory Kit 0336 Circulaire II Aerosol Drug Delivery System