Disposable, Non-Heated Adult Passive Circuit

GUDID 10709078008808

Disposable Adult non-heated 22mm, 1.9m (6ft, 3in) circuit, passive

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078008808
• NIH Device Record Key: f8d54a09-e957-4ebf-b2e7-8a239b5a207d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable, Non-Heated Adult Passive Circuit
• Version Model Number: 6564
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078008801 [Primary]
GS1	10709078008808 [Package]; Contains: 00709078008801; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2020-08-10
• Device Publish Date: 2020-07-31

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