SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60

GUDID 04716770224251

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04716770224251
• NIH Device Record Key: 5f7f80d8-cccd-4f4b-a9c6-a8455051cf69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60
• Version Model Number: RE-22425
• 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	04716770224251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021442

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 [SINGLE USE ADULT 1600ML RESUSCITATOR W/ POP-OFF 60]

• 04716770244433: RE-24443
• 04716770244402: RE-24440
• 04716770244204: RE-24420
• 04716770224459: RE-22445
• 04716770224251: RE-22425