CPR Shield

GUDID 00616784492322

CPR Shield in Soft Case with one-way valve and barrier filter

DYNAREX CORPORATION

Cardiopulmonary resuscitation mask, single-use

• Primary Device ID: 00616784492322
• NIH Device Record Key: 0c7cca03-ea2b-44be-b740-9731e7fc9f27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPR Shield
• Version Model Number: 4923
• 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: false
• 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	00616784492322 [Unit of Use]
GS1	00616784492339 [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: 2021-09-09
• Device Publish Date: 2021-09-01

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