Comfort Soft Plus CO2 Sampling Nasal Cannula

GUDID 00709078004438

WESTMED, INC.

Carbon-dioxide-sampling nasal oxygen cannula

• Primary Device ID: 00709078004438
• NIH Device Record Key: 603c9eed-0ed1-48da-b275-8f55ea8b1eea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Soft Plus CO2 Sampling Nasal Cannula
• Version Model Number: 0503-01
• 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: 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	00709078004438 [Primary]

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-21

On-Brand Devices [Comfort Soft Plus CO2 Sampling Nasal Cannula]

• 10709078005647: Adult Nasal Cannula, o2/co2, Sampling line w/Male Luer, 0.8 Micron Filter
• 10709078005630: Pediatric Nasal Cannula, O2/CO2 Sampling Line w/Female Luers, 0.8 Micron Filter
• 00709078004438: 0503-01
• 10709078001496: Adult nasal Cannula, V-Cut 10' O2/CO2 0.045 ID sampling line w/male luer
• 10709078001489: Adult nasal Cannula, 10' O2/CO2 0.045 ID sampling line w/male luer
• 10709078001472: Adult nasal Cannula, 14' O2 line, 2' CO2 sampling line w/ male luer
• 00709078001468: Adult nasal Cannula, V-Cut, 10' O2/CO2 Sampling line w/ male luer, 2" pigtail w/female luers
• 10709078001458: Adult nasal Cannula, O2/CO2 Sampling line w/ female luer, ETCO2 Only Label
• 10709078001441: Adult nasal Cannula, 7' O2, 2" CO2 Sampling Line w/female luer
• 00709078001437: Adult nasal Cannula, 14' O2/CO2 Sampling Line w/male luer, 2" pigtail w/female luers
• 10709078001427: Adult nasal Cannula, 10' O2/CO2 Sampling Line w/female Luer
• 10709078001410: Adult nasal Cannula, 10' O2/CO2 Sampling Line w/male Luer
• 00709078001406: Adult nasal Cannula, O2/CO2 Sampling Line w/female Luer
• 10709078001397: Adult nasal Cannula, O2/CO2 Sampling Line w/Male Luer