Elite CPR Face Shield Not Applicable

GUDID 00816703023129

CPR Face Shield / Elite First Aid Part Number: 605

MEDSOURCE INTERNATIONAL LLC

Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover Cardiopulmonary resuscitation mouthpiece/cover

• Primary Device ID: 00816703023129
• NIH Device Record Key: 219eb139-bac7-4d73-9321-98e9a93214eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elite CPR Face Shield
• Version Model Number: ELITE-21105
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00816703023112 [Primary]
GS1	00816703023129 [Package]; Contains: 00816703023112; Package: Case [400 Units]; In Commercial Distribution

FDA Product Code

• KGB: Mask, Oxygen, Non-Rebreathing

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-11-29
• Device Publish Date: 2021-04-20

On-Brand Devices [Elite CPR Face Shield]

• 00816703023143: CPR Face Shield w/o case / Elite First Aid Part Number: 604
• 00816703023129: CPR Face Shield / Elite First Aid Part Number: 605