SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF,L

GUDID 04716770244334

BESMED HEALTH BUSINESS CORP.

Pulmonary resuscitator, manual, single-use

• Primary Device ID: 04716770244334
• NIH Device Record Key: 2c289e52-6f5f-4dc5-a8b9-9df49bb3d445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF,L
• Version Model Number: RE-24433
• 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	04716770244334 [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/O POP-OFF,L]

• 04716770244631: SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF,L TYPE ADAPTER(ALL IN ONE-INTAKE VALVE)
• 04716770244334: RE-24433
• 04716770244327: SINGLE USE ADULT 1600ML RESUSCITATOR W/O POP-OFF,L TYPE ADAPTER.