MedSource Rebreather Mask Not Applicable

GUDID 00840155400054

Rebreather, Ped, Elongated w/ U. Conn

MEDSOURCE INTERNATIONAL LLC

Rebreathing oxygen face mask

• Primary Device ID: 00840155400054
• NIH Device Record Key: 38b4c9ae-5231-462a-9c17-dee4bf16af34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Rebreather Mask
• Version Model Number: MS-25056-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	00840155400047 [Primary]
GS1	00840155400054 [Package]; Contains: 00840155400047; 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.