RESUSCITATOR MANOMETER POP OFF CHILD

GUDID 04716770214542

BESMED HEALTH BUSINESS CORP.

Airway pressure monitor, non-powered

• Primary Device ID: 04716770214542
• NIH Device Record Key: e7fc9099-f91c-461b-835e-04548fe7afa0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESUSCITATOR MANOMETER POP OFF CHILD
• Version Model Number: RE-21454
• Company DUNS: 658023775
• Company Name: BESMED HEALTH BUSINESS CORP.
• 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	04716770214542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140370

FDA Product Code

• CAP: Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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: 2016-09-06

On-Brand Devices [RESUSCITATOR MANOMETER POP OFF CHILD]

• 04716770214641: RE-21464
• 04716770214542: RE-21454