Uni-Lim 72" Adult Coaxail Breathing Circuit

GUDID 10709078009331

Uni-Lim 72" Adult Coaxail Breathing Circuit, Anesthesia, w/24" flex expiratory lead, GSE w/CAP, B/V Filter, 3L not made with latex breathing bag

WESTMED, INC.

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• Primary Device ID: 10709078009331
• NIH Device Record Key: 2aef4bca-4c52-43bd-95f0-1d65108b131d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-Lim 72" Adult Coaxail Breathing Circuit
• Version Model Number: 8994
• 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	00709078009334 [Primary]
GS1	10709078009331 [Package]; Contains: 00709078009334; 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 72" Adult Coaxail Breathing Circuit]

• 10709078009409: Uni-Lim 72" Adult Coaxail Breathing Circuit, GSE, B/V Filter, 3L not made with latex breathing b
• 10709078009331: Uni-Lim 72" Adult Coaxail Breathing Circuit, Anesthesia, w/24" flex expiratory lead, GSE w/CAP,
• 10709078009270: Uni-Lim 72" Adult Coaxail Breathing Circuit, 24" Flex Expiratory, GSE w/CAP
• 10709078009263: Uni-Lim 72" Adult Coaxail Breathing Circuit, 24" flex expiratory, clear GSE, GSL 10' x .060" ID
• 00709078009068: Uni-Lim 72" Adult Coaxail Breathing Circuit, 24" Flex Expiratory GSE w/Cap, B/V Filter, 2L not m
• 00709078009020: Uni-Lim 72" Adult Coaxail Breathing Circuit, GSE, In-Line Mini HMEF, 3L not made with latex bag,
• 00709078008924: Uni-Lim 72" Adult Coaxail Breathing Circuit 10' x .050 ID Swivel GSL, Adult Large Mask, 2L not m