SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40C

GUDID 04716770223353

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 04716770223353
• NIH Device Record Key: 80b17e5a-fd73-4339-9bbb-1e690021c680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40C
• Version Model Number: RE-22335
• 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	04716770223353 [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 INFANT 280ML RESUSCITATOR W/ POP-OFF 40C]

• 04716770243252: RE-24325
• 04716770243207: SILICONE INFANT 280ML RESUSCITATOR W/ POP-OFF 40CM H2O (ALL IN ONE-INTAKE VALVE)
• 04716770243153: RE-24315
• 04716770233406: RE-23340
• 04716770233208: RE-23320
• 04716770233109: RE-23310
• 04716770223353: RE-22335
• 04716770223155: RE-22315