Comfort Soft Plus CO2/O2 Mask

GUDID 10709078001694

adult CO2/O2 Mask, 10' x 0.050 GSL w swivel elbow, 2" Pigtail w/ female luer connectors, 7' oxygen supply tubing

WESTMED, INC.

Tube/mask breathing circuit connector, single-use, non-sterile

• Primary Device ID: 10709078001694
• NIH Device Record Key: 0d275a79-1fab-4349-94f0-5558fe6725f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Soft Plus CO2/O2 Mask
• Version Model Number: 0562
• 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	00709078001697 [Primary]
GS1	10709078001694 [Package]; Contains: 00709078001697; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• CAT: Cannula, Nasal, Oxygen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-23
• Device Publish Date: 2017-01-06

On-Brand Devices [Comfort Soft Plus CO2/O2 Mask]

• 00709078004445: 0562-01
• 10709078001694: adult CO2/O2 Mask, 10' x 0.050 GSL w swivel elbow, 2" Pigtail w/ female luer connectors, 7' oxyg