Comfort Soft Plus CO2/O2 Mask

GUDID 00709078004445

WESTMED, INC.

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• Primary Device ID: 00709078004445
• NIH Device Record Key: ff18bdee-3fea-48eb-a7c5-7e9adffabc62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfort Soft Plus CO2/O2 Mask
• Version Model Number: 0562-01
• 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	00709078004445 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)

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: 2019-11-27
• Device Publish Date: 2017-10-26

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