BREATHING CIRCUIT

GUDID 10709078000666

Anesthesia Circuit, Adult, 108” Expandable GSE w/Cap, Parallel WYE, GSL 10’ x .060” ID M/M, 3L Latex Free Breathing Bag, BV Filters, Series 700 Large Adult Mask

WESTMED, INC.

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 10709078000666
• NIH Device Record Key: 634b23ad-45a3-46e6-8f7d-65a6dcda2d77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BREATHING CIRCUIT
• Version Model Number: 9076
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.
• Special Storage Condition, Specify: Between 0 and 0 *Do not soak, rinse, wash, gas, or steam sterilize this product.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078000669 [Primary]
GS1	10709078000666 [Package]; Contains: 00709078000669; Package: [20 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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-23

Devices Manufactured by WESTMED, INC.

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• 20889483612054 - Anesthesia Circuit Kit: 2024-06-10 96" Adult Exp.Anes.Circuit,Par-Wye,GSE W/Cap