CPR-Bag

GUDID 30641043564145

MERCURY ENTERPRISES, INC.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 30641043564145
• NIH Device Record Key: ba969a3f-fb64-457c-baf0-123b53adcc01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CPR-Bag
• Version Model Number: 10-56414
• Company DUNS: 032705659
• Company Name: MERCURY ENTERPRISES, 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: true
• 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

Customer Support Contacts

• Phone: 727-573-0088
• Email: hospitalcustomerservice@mercurymed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10641043564141 [Primary]
GS1	30641043564145 [Package]; Contains: 10641043564141; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911622

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2020-04-27
• Device Publish Date: 2020-04-17

On-Brand Devices [CPR-Bag]

• 30641043564466: 10-56446
• 30641043564145: 10-56414
• 30641043564473: 10-56447