Disposable Respiratory Circuits

GUDID 10709078008877

Circuit, Disposable, 15mm, Non-Heated, Passive

WESTMED, INC.

Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078008877
• NIH Device Record Key: 1fbef655-c5bb-4258-ab1b-715c25f2ec06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Respiratory Circuits
• Version Model Number: 6513
• 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: true
• Expiration Date: false
• 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	00709078008870 [Primary]
GS1	10709078008877 [Package]; Contains: 00709078008870; Package: Case [10 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: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [Disposable Respiratory Circuits]

• 10709078008877: Circuit, Disposable, 15mm, Non-Heated, Passive
• 10709078011822: Tubing, Corrugated, 18" x 22mm (6" Segments)
• 10709078011815: Hose, 22mm x 22mm, 100' Coil, Segmented Blue
• 10709078011808: Tubing, Segmented, Magenta, 19mm x 19mm, 100" Coil
• 10709078011839: Tubing, Flex Hose, 60", w/Cuffs
• 10709078011631: Pedi-Lim, 40" Pediatric Coaxial Circle Anesthesia Breathing Circuit x/24" Flex Expiratory Lead,
• 10709078011624: Anesthesia Circuit, Pedi-Lim, 60", GSE w/CAP. GSL, B/V Filters, 2L Not Made With Latex Bag
• 10709078011341: Respiratory Circuit, Adult, 72", Bi-Wye W/Temp Port, 2 Water Traps, Plain Elbow, Tube Hanger, Ca
• 10709078011334: 72" Adult Respiratory Circuit, Plain Elbow, Bi-Wye W/Temp Port, Caps, Tube Hanger, 22mm Adapter
• 10709078011297: Anesthesia Circuit, Expandable, Adult, 120", Par Wye, GSE, Tubing W/Cuffs, 2L Bag, Adaptor, B/V
• 10709078011143: Anesthesia Circuit, Adult, 72", GSE W/CAP, Parallel Wye, B/V Filter
• 10709078012935: Pediatric Circuit, 96" Expandable GSE, Parallel wye, (2) B/V Filters, 10' x .050" ID M/M GSL
• 00709078013676: Adult 60" Ventilator Circuit