CPR Shield w/one way valve

GUDID 00616784492131

DYNAREX CORPORATION

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 00616784492131
• NIH Device Record Key: 221d31c9-be7a-4a9a-a7f6-b391d0422410
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPR Shield w/one way valve
• Version Model Number: 4921
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• 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: true
• Expiration Date: false
• 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	00616784492117 [Unit of Use]
GS1	00616784492131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052743

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: 2018-09-18
• Device Publish Date: 2018-08-18

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