MedSource Disposable Resuscitator, Pediatric (10/cs)

GUDID 00816703021293

Disposable Resuscitator, Pediatric (10/cs)

MEDSOURCE INTERNATIONAL LLC

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 00816703021293
• NIH Device Record Key: 271e882e-ccd5-4aaa-91b1-4ee2e55a964f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Disposable Resuscitator, Pediatric (10/cs)
• Version Model Number: MS-6220
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• 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: true
• 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	00816703021293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002846

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-14

Devices Manufactured by MEDSOURCE INTERNATIONAL LLC

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