Anesthesia Circuit

GUDID 10709078008655

60" Neonatal Anesthesia Circuit

WESTMED, INC.

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• Primary Device ID: 10709078008655
• NIH Device Record Key: 5b16eb7a-9ef4-42cf-abd8-9561823b1f0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anesthesia Circuit
• Version Model Number: 8267
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078008658 [Primary]
GS1	10709078008655 [Package]; Contains: 00709078008658; Package: Case [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: 2020-06-08
• Device Publish Date: 2020-05-29

On-Brand Devices [Anesthesia Circuit]

• 00709078006111: Anesthesia Circuit, Pediatric, 200" Expandable, Parallel WYE, GSE w/CAP, 1L Not made with Latex
• 10709078006101: Anesthesia Circuit, Adult, 200" 22/22mm Expandable, Parallel WYE, GSE, Clear, 3L Latex Free Bag,
• 10709078004329: Disposable Anesthesia Circuits, Adult 60" Corrugated Tubing
• 10709078006323: Anesthesia Circuit, Adult, UNI-LIM, 72" GSE, 10' x .050 ID M/M GSE, 3L Latex Free Bag, B/V Filte
• 10709078006316: Anesthesia Circuit, Pediatric, 72", Parallel WYE. GSE, 2L Not Made with Breathing Bag, 10' x .05
• 10709078008655: 60" Neonatal Anesthesia Circuit
• 00709078013171: Anesthesia Circuit, Adult, 108" Expandable, Parallel Wye w/Port and Cap, GSE, In-line Mini HMEF,
• 10709078013864: 120" Adult Anesthesia