Disposable Anesthesia Breathing Circuits

GUDID 10709078009492

96" Expandable Adult Anesthesia Circuit, Parallel Wye W/GSP, GSE, 900 Series Large Adult Mask, (2) Bacterial Gilters, 3L Not Made With Latex Breathing Bag, 10' x 0.060 ID mm GSL

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078009492
• NIH Device Record Key: 7ffb1776-9967-4de8-b102-35a53ad67650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Anesthesia Breathing Circuits
• Version Model Number: 8095
• 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: false
• 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	00709078009495 [Primary]
GS1	10709078009492 [Package]; Contains: 00709078009495; Package: Case [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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Disposable Anesthesia Breathing Circuits]

• 10709078004732: 108" Pediatric Expandable Circuit
• 10709078009546: Anesthesia Circuit, Adult, 96" Expandable, Parallel Wye, HMEF, GSE, 2L Not Made With Latex Textu
• 10709078009508: Anesthesia Circuit, Pediatric, 108" Expandable, Plain Elbow, Parallel Wye, GSL 10' x .047" ID M/
• 10709078009492: 96" Expandable Adult Anesthesia Circuit, Parallel Wye W/GSP, GSE, 900 Series Large Adult Mask, (
• 10709078009485: Anesthesia Circuit, Adult, 108" Expandable, Parallel Wye W/Port and Cap, Inner Elbow, GSL 10' x
• 10709078009478: Anesthesia Circuit, Adult, 60", GSE W/Cap, Parallel Wye, 2L Not Made With Latex Breathing Bag