Pedi-Lim Breathing Circuit

GUDID 10709078011679

Anesthesia Circuit, Ped-Lim, 60", GSE clear, 10' x .050" ID M/M, GSL, 2 B/V Filters

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078011679
• NIH Device Record Key: 6099ead0-55b1-4e71-9037-0aed7a210529
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pedi-Lim Breathing Circuit
• Version Model Number: 9060
• 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	00709078011672 [Primary]
GS1	10709078011679 [Package]; Contains: 00709078011672; 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: 2020-10-08
• Device Publish Date: 2020-09-30

On-Brand Devices [Pedi-Lim Breathing Circuit]

• 10709078011679: Anesthesia Circuit, Ped-Lim, 60", GSE clear, 10' x .050" ID M/M, GSL, 2 B/V Filters
• 10709078011662: Pedi-Lim, 60" Pediatric Coaxial Circle Anesthesia breathing circuit w/24" flex expiratory Lead i
• 10709078011655: Pedi-Lim, 60" Pediatric Coaxial Breathing Circuit, 24" flex expiratory, GSE w/CAP