Uni-Lim Coaxial Circuit

GUDID 10709078013796

Uni-Lim™, 84", Adult Coaxial Circle Anesthesia Breathing Circuit w/24" Flex Expiratory Lead, GSE, (2) BV Filters, 3Lf Bag, 10' x .050 ID, GSL w/swivel elbow, Large Adult Mask

WESTMED, INC.

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• Primary Device ID: 10709078013796
• NIH Device Record Key: 51f53776-5ba7-4b54-b568-7d8b8950cbff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Uni-Lim Coaxial Circuit
• Version Model Number: 9697
• 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	00709078013799 [Primary]
GS1	10709078013796 [Package]; Contains: 00709078013799; Package: Case [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: 2022-01-03
• Device Publish Date: 2021-12-24

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