Disposable Anesthesia Breathing Circuit

GUDID 00709078009518

Anesthesia Circuit, 96" Expandable, GSE w/Cap, Parallel Wye x/Port, GSL 10' x .060" ID M/M, 3L Not Made With Latex Breathing Bag, B/V Filter, Large Adult Mask 900 Series, In-Line Mini HME

WESTMED, INC.

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• Primary Device ID: 00709078009518
• NIH Device Record Key: 44ac068b-e33b-4d62-ab18-2e521d1fe465
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Anesthesia Breathing Circuit
• Version Model Number: 8624A
• 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	00709078009518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• OFP: Anesthesia Breathing Circuit Kit (Adult & Pediatric)

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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Disposable Anesthesia Breathing Circuit]

• 10709078006293: UNI-LIM, 72' Adult, Mini HMEP GSL, LG Adult Mask 2L Not made with Latex Bag, Hose Clip GSE
• 10709078008617: Anesthesia, Pediatric, 72"
• 10709078009539: Anesthesia Circuit, Adult, 96" Expandable, GSE W/Cap, GSL 10' c .050" ID M/M, B/V Filter, 3L Not
• 10709078009522: Anesthesia Circuit, Pediatric, 96" Expandable, GSE w/Cap, Parallel Wye, GSL 10' x .060" ID M/M 2
• 00709078009518: Anesthesia Circuit, 96" Expandable, GSE w/Cap, Parallel Wye x/Port, GSL 10' x .060" ID M/M, 3L N