SILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFF

GUDID 04716770221151

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, pneumatic, reusable

• Primary Device ID: 04716770221151
• NIH Device Record Key: 956649c6-60c6-4485-bc77-87c95c9d8d0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILICONE ADULT 1600ML RESUSCITATOR W/O POP-OFF
• Version Model Number: RE-22115
• 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	04716770221151 [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/O POP-OFF ]

• 04716770241258: RE-24125
• 04716770241159: RE-24115
• 04716770221250: RE-22125
• 04716770221151: RE-22115