WORK'N

GUDID 04719871890936

5001SGI-Adult / Child &Infant CPR Mask w/ Zip Lock Bag

FOREMOUNT ENTERPRISE CO., LTD.

Resuscitator face mask, single-use

• Primary Device ID: 04719871890936
• NIH Device Record Key: 4ad16642-209b-435a-9684-3e7d8b17e04e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WORK'N
• Version Model Number: ME6201Z-5001SGI
• 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	04719871890936 [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