One Pacific

GUDID 04719871891889

CPR Mask in Red Soft Case Adult/Child

FOREMOUNT ENTERPRISE CO., LTD.

Resuscitator face mask, single-use

• Primary Device ID: 04719871891889
• NIH Device Record Key: d1aa4b8d-773c-4ccf-81e5-00ef15e27345
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Pacific
• Version Model Number: ME6201KNB-MG100
• Company DUNS: 658718465
• Company Name: FOREMOUNT ENTERPRISE CO., LTD.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871891889 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042727

FDA Product Code

• CBP: Valve, Non-Rebreathing

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: 2024-07-08
• Device Publish Date: 2024-06-28

Devices Manufactured by FOREMOUNT ENTERPRISE CO., LTD.

• 04719871892251 - JBC: 2024-07-26 Heat And Moisture Exchange Filters (HMEF)
• 04719871890011 - WNL: 2024-07-08 CPR Resuscitator in red hard case Adult/Child Infant
• 04719871890028 - WNL: 2024-07-08 CPR Mask in Red Soft Case Adult/Child Infant with mask
• 04719871890042 - WNL: 2024-07-08 CPR Mask in Red Soft Case Adult/Child Infant
• 04719871890059 - WNL: 2024-07-08 CPR Resuscitator in red hard case Adult/Child Infant with mask
• 04719871890066 - ARC: 2024-07-08 CPR Mask in Red Soft Case Adult/Child Infant
• 04719871890073 - WNL: 2024-07-08 Replacement Valve for CPR Mask
• 04719871890080 - Fukuoka: 2024-07-08 CPR Mask in Blue Soft Case Adult/Child Infant