MedSource Rebreather Mask Not Applicable

GUDID 00840155400016

Rebreather, Infant, Under-Lip, U. Conn.

MEDSOURCE INTERNATIONAL LLC

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• Primary Device ID: 00840155400016
• NIH Device Record Key: 03baeebc-c2da-4b06-823b-b11b42dd9904
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Rebreather Mask
• Version Model Number: MS-25054-U
• 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: false
• Expiration Date: true
• 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	00840155400009 [Primary]
GS1	00840155400016 [Package]; Contains: 00840155400009; Package: Case [50 Units]; In Commercial Distribution

FDA Product Code

• BYW: Device, 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: 2021-06-04
• Device Publish Date: 2021-05-27

On-Brand Devices [MedSource Rebreather Mask]

• 00840155400054: Rebreather, Ped, Elongated w/ U. Conn
• 00840155400016: Rebreather, Infant, Under-Lip, U. Conn.