120" Anesthesia Breathing Circuit

GUDID 00709078009662

120" Anesthesia Breathing Circuit, B/V Filter, GSE 10' x .060 ID M/M GSL, In-line Mini HMEF, Parallel WYE w/Temperature Port and GSP, 3L not made made with latex bag, 900 large adult mask

WESTMED, INC.

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• Primary Device ID: 00709078009662
• NIH Device Record Key: 343398cd-512e-455b-812d-b9ed7ed38c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 120" Anesthesia Breathing Circuit
• Version Model Number: 9187
• 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	00709078009662 [Primary]
GS1	10709078009669 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-08
• Device Publish Date: 2020-08-31

Devices Manufactured by WESTMED, INC.

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• 30889483608955 - Anesthesia Circuit Kit: 2023-12-28 96" flexible dual limb | patient elbow with sampling port parallel wye | in-line mini HMEF with sample port large adult mask | M
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• 30889483608986 - Anesthesia Circuit Kit: 2023-12-28 60" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1
• 30889483608993 - Anesthesia Circuit Kit: 2023-12-28 72" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, 2L late
• 30889483609006 - Anesthesia Circuit Kit: 2023-12-28 120" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1