CPR Bio-Barrier Training Faceshield 01RB5050

GUDID 17540195056029

CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. The use if this device does not guarantee complete protection from disease transmission.

O-Two Medical Technologies Inc

Face splash shield, single-use

• Primary Device ID: 17540195056029
• NIH Device Record Key: 398457ff-783e-4138-8e82-d571028eff78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPR Bio-Barrier Training Faceshield
• Version Model Number: 01RB5050U
• Catalog Number: 01RB5050
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies Inc
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195056008 [Primary]
GS1	17540195056029 [Package]; Contains: 07540195056008; Package: Dispenser pouch [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960995

FDA Product Code

• CBP: Valve, 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: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-02-03

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