WorldPoint

GUDID 04719871890646

CPR Resuscitator in lage blue case Adult

FOREMOUNT ENTERPRISE CO., LTD.

Resuscitator face mask, single-use

• Primary Device ID: 04719871890646
• NIH Device Record Key: 85caa573-07f3-43b8-84d5-4c80ac888533
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WorldPoint
• Version Model Number: ME6201-WP600
• 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	04719871890646 [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

On-Brand Devices [WorldPoint]

• 04719871890738: CPR Resuscitator in blue soft case Adult
• 04719871890707: CPR Mask in Blue Soft Case Adult & Infant
• 04719871890646: CPR Resuscitator in lage blue case Adult