SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60C

GUDID 04716770221458

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 04716770221458
• NIH Device Record Key: 10326413-9917-43b8-b1f0-c12b5cc0386d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60C
• Version Model Number: RE-22145
• 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: false
• 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	04716770221458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021446

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: 2016-05-23

On-Brand Devices [ SILICONE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60C]

• 04716770241852: RE-24185
• 04716770241357: RE-24135
• 04716770221458: RE-22145
• 04716770221359: RE-22135