96" Anesthesia Circuit

GUDID 10709078010139

96" Pediatric Anesthesia Circuit, GSE, w/Cap, Parallel WYE, GSL 10' x .060" ID M/M 1L Not made with latex breathing bag, B/V Filter, In-Line Mini HME

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078010139
• NIH Device Record Key: 40938a91-bc24-458f-b4da-38912df73347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 96" Anesthesia Circuit
• Version Model Number: 9435
• 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	00709078010132 [Primary]
GS1	10709078010139 [Package]; Contains: 00709078010132; 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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [96" Anesthesia Circuit ]

• 10709078010139: 96" Pediatric Anesthesia Circuit, GSE, w/Cap, Parallel WYE, GSL 10' x .060" ID M/M 1L Not made w
• 10709078012904: Anesthesia Circuit, Adult, 96" Expandable GSE, Parallel Wye, 3L Not Made With Latex Breathing Ba