Anesthesia/Breathing Circuits

GUDID 10709078014540

72" Adult Uni-Lim Coaxial Anesthesia Breathing Circuit, GSE, 3L Latex free Bag, 10' x .060" ID M/M GSL, Large Adult Mask, In-Line Maxi HMEF

WESTMED, INC.

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• Primary Device ID: 10709078014540
• NIH Device Record Key: 769012b2-dea0-49fe-ad7e-3fd73595af00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anesthesia/Breathing Circuits
• Version Model Number: 6901
• 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: false
• Serial Number: true
• 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	00709078014543 [Primary]
GS1	10709078014540 [Package]; Contains: 00709078014543; Package: [20 Units]; In Commercial Distribution

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: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [Anesthesia/Breathing Circuits]

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• 10709078014588: Disposable 96" Adult Expandable Anesthesia Circuit
• 10709078014571: 72" Adult Corrugated Anesthesia Circuit, GSE, Parallel WYE, Maxi HMEF, B/V Filter, Large Adult M
• 10709078014564: 60" Neonatal Corrugated Anesthesia Circuit, Neonatal HMEF, B/V Filter, 1/2 not made with latex b
• 10709078014557: 72" Pediatric Corrugate Anesthesia Circuit, GSE, Parallel WYE, HMEF, B/V Filter, Pediatric Mask,
• 10709078014540: 72" Adult Uni-Lim Coaxial Anesthesia Breathing Circuit, GSE, 3L Latex free Bag, 10' x .060" ID M
• 10709078014533: 120" Neonatal Expandable Circuit, Parallel WYE, 2() B/V Filters, Adult Vent Mask, 1/2L not made
• 10709078014526: 120" Pediatric Expandable Circuit, Parallel WYE, 2() B/V Filters, Mini HEMF W/ CO2 Port, 1L not
• 10709078014519: 120" Adult 22mm/2mm Expandable Circuit, Parallel WYE, 2() B/V Filters, Mini HEMF W/ CO2 Port, Ad