Uni-Lim 120" Adult Coaxial Breathing Circuit

GUDID 00709078009389

Uni-Lim 120" Adult Coaxial Breathing Circuit, 24" Flex Expiratory, GSE, B/V Filter, 3L Not made with latex

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 00709078009389
• NIH Device Record Key: 876fbdc5-73fb-47cc-9b64-d35eb7ad02d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-Lim 120" Adult Coaxial Breathing Circuit
• Version Model Number: 9096
• 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	00709078009389 [Primary]
GS1	10709078009386 [Package]; Package: [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: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [Uni-Lim 120" Adult Coaxial Breathing Circuit]

• 10709078009430: Uni-Lim 120" Adult Coaxial Breathing Circuit 24" Flex Expiratory, GSE, B/V Filter, InLine Mini H
• 00709078009389: Uni-Lim 120" Adult Coaxial Breathing Circuit, 24" Flex Expiratory, GSE, B/V Filter, 3L Not made
• 10709078009201: Uni-Lim 120" Adult Coaxial Breathing Circuit, 24" Flex Expiratory, Plain Elbow